Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants (NCT NCT03934541)
NCT ID: NCT03934541
Last Updated: 2025-09-25
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
1
|
3
|
|
Overall Study
COMPLETED
|
5
|
14
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24 years
n=99 Participants
|
29 years
n=107 Participants
|
30 years
n=206 Participants
|
23 years
n=7 Participants
|
27 years
n=31 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Customized
21 - 30 years
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Age, Customized
31 - 40 years
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose at Months (0,2,6,12)Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
2 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose at Months (0,2,6,12)Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · None
|
3 Participants
|
12 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Not Gradable
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 3: >=10 cm dim.
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
2 Participants
|
12 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not Gradable
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >=10 cm dim.
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 4: Complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · None
|
3 Participants
|
14 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Not Gradable
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 2: 5 to less than 10 cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Gr 3: >=10 cm dim.
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose at Months (0,2,6,12)Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
3 Participants
|
13 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
1 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
4 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
3 Participants
|
10 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
4 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
4 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · None
|
5 Participants
|
15 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
4 Participants
|
14 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
3 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature (C) · Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Baseline
|
14 U/L
Interval 13.0 to 20.0
|
15 U/L
Interval 11.0 to 20.0
|
17 U/L
Interval 17.0 to 17.0
|
14 U/L
Interval 11.0 to 17.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 14
|
21 U/L
Interval 10.0 to 23.0
|
11 U/L
Interval 10.0 to 19.0
|
15 U/L
Interval 15.0 to 15.0
|
12 U/L
Interval 8.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 70
|
14 U/L
Interval 11.0 to 27.0
|
14 U/L
Interval 11.0 to 16.0
|
15 U/L
Interval 15.0 to 15.0
|
9 U/L
Interval 9.0 to 13.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Alanine Aminotransferase (U/L)-Day 182
|
19 U/L
Interval 13.5 to 40.5
|
16 U/L
Interval 14.0 to 18.0
|
16 U/L
Interval 16.0 to 16.0
|
13 U/L
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Baseline
|
0.97 mg/dL
Interval 0.78 to 1.0
|
0.73 mg/dL
Interval 0.7 to 0.85
|
0.68 mg/dL
Interval 0.68 to 0.68
|
0.7 mg/dL
Interval 0.69 to 0.81
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 14
|
1 mg/dL
Interval 0.96 to 1.07
|
0.7 mg/dL
Interval 0.67 to 0.8
|
0.74 mg/dL
Interval 0.74 to 0.74
|
0.82 mg/dL
Interval 0.63 to 0.96
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 70
|
0.92 mg/dL
Interval 0.9 to 1.01
|
0.72 mg/dL
Interval 0.65 to 0.8
|
0.76 mg/dL
Interval 0.76 to 0.76
|
0.83 mg/dL
Interval 0.74 to 0.93
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL)-Day 182
|
0.88 mg/dL
Interval 0.82 to 0.96
|
0.78 mg/dL
Interval 0.75 to 0.81
|
0.82 mg/dL
Interval 0.82 to 0.82
|
0.71 mg/dL
Interval 0.71 to 0.71
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Baseline
|
14 g/dL
Interval 13.0 to 16.0
|
14 g/dL
Interval 13.0 to 14.0
|
14 g/dL
Interval 14.0 to 14.0
|
14 g/dL
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 14
|
13 g/dL
Interval 13.0 to 15.0
|
13 g/dL
Interval 12.0 to 14.0
|
13 g/dL
Interval 13.0 to 13.0
|
13 g/dL
Interval 11.0 to 13.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 70
|
13 g/dL
Interval 13.0 to 15.0
|
13 g/dL
Interval 12.0 to 14.0
|
15 g/dL
Interval 15.0 to 15.0
|
12 g/dL
Interval 11.0 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 182
|
14 g/dL
Interval 13.0 to 15.0
|
12 g/dL
Interval 12.0 to 13.0
|
14 g/dL
Interval 14.0 to 14.0
|
14 g/dL
Interval 14.0 to 14.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Baseline
|
2.44 1000 cells/cubic mm
Interval 2.2 to 2.508
|
2.09 1000 cells/cubic mm
Interval 1.84 to 2.227
|
2.39 1000 cells/cubic mm
Interval 2.39 to 2.39
|
2.587 1000 cells/cubic mm
Interval 2.335 to 2.7
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 14
|
2.25 1000 cells/cubic mm
Interval 1.84 to 2.677
|
2.027 1000 cells/cubic mm
Interval 1.77 to 2.563
|
1.87 1000 cells/cubic mm
Interval 1.87 to 1.87
|
1.876 1000 cells/cubic mm
Interval 1.626 to 3.14
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 70
|
2.27 1000 cells/cubic mm
Interval 2.04 to 2.391
|
2.017 1000 cells/cubic mm
Interval 1.81 to 2.5
|
1.88 1000 cells/cubic mm
Interval 1.88 to 1.88
|
1.811 1000 cells/cubic mm
Interval 1.793 to 2.48
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)-Day 182
|
2.53 1000 cells/cubic mm
Interval 2.405 to 3.085
|
2.335 1000 cells/cubic mm
Interval 1.68 to 2.99
|
1.77 1000 cells/cubic mm
Interval 1.77 to 1.77
|
2.67 1000 cells/cubic mm
Interval 2.67 to 2.67
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Baseline
|
4.42 1000 cells/cubic mm
Interval 3.05 to 4.68
|
3.79 1000 cells/cubic mm
Interval 2.96 to 4.61
|
4.48 1000 cells/cubic mm
Interval 4.48 to 4.48
|
5.216 1000 cells/cubic mm
Interval 4.612 to 6.14
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 14
|
3.99 1000 cells/cubic mm
Interval 3.0 to 4.12
|
3.76 1000 cells/cubic mm
Interval 2.9 to 4.76
|
1.99 1000 cells/cubic mm
Interval 1.99 to 1.99
|
5.7 1000 cells/cubic mm
Interval 4.963 to 8.238
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 70
|
3.8 1000 cells/cubic mm
Interval 2.94 to 4.12
|
3.47 1000 cells/cubic mm
Interval 2.808 to 5.39
|
1.55 1000 cells/cubic mm
Interval 1.55 to 1.55
|
5.412 1000 cells/cubic mm
Interval 4.757 to 6.33
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)-Day 182
|
4.135 1000 cells/cubic mm
Interval 3.77 to 4.89
|
3.93 1000 cells/cubic mm
Interval 2.97 to 4.89
|
1.91 1000 cells/cubic mm
Interval 1.91 to 1.91
|
5.78 1000 cells/cubic mm
Interval 5.78 to 5.78
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Baseline
|
7.61 1000 cells/cubic mm
Interval 6.37 to 9.0
|
6.51 1000 cells/cubic mm
Interval 5.9 to 7.44
|
7.6 1000 cells/cubic mm
Interval 7.6 to 7.6
|
8.4 1000 cells/cubic mm
Interval 7.7 to 9.47
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 14
|
7.28 1000 cells/cubic mm
Interval 6.53 to 8.01
|
6.54 1000 cells/cubic mm
Interval 5.2 to 7.56
|
4.53 1000 cells/cubic mm
Interval 4.53 to 4.53
|
9.83 1000 cells/cubic mm
Interval 7.1 to 11.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 70
|
6.93 1000 cells/cubic mm
Interval 5.76 to 7.27
|
6.38 1000 cells/cubic mm
Interval 5.26 to 8.77
|
4.04 1000 cells/cubic mm
Interval 4.04 to 4.04
|
8.3 1000 cells/cubic mm
Interval 7.1 to 9.61
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)-Day 182
|
7.91 1000 cells/cubic mm
Interval 7.37 to 8.66
|
7.12 1000 cells/cubic mm
Interval 5.41 to 8.83
|
4.32 1000 cells/cubic mm
Interval 4.32 to 4.32
|
9.19 1000 cells/cubic mm
Interval 9.19 to 9.19
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Baseline
|
229 1000 cells/cubic mm
Interval 218.8 to 235.0
|
250 1000 cells/cubic mm
Interval 220.2 to 323.0
|
242 1000 cells/cubic mm
Interval 242.0 to 242.0
|
290 1000 cells/cubic mm
Interval 267.0 to 294.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 14
|
218 1000 cells/cubic mm
Interval 211.0 to 264.0
|
277 1000 cells/cubic mm
Interval 240.0 to 347.9
|
227 1000 cells/cubic mm
Interval 227.0 to 227.0
|
306 1000 cells/cubic mm
Interval 288.0 to 353.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 70
|
237 1000 cells/cubic mm
Interval 197.6 to 279.0
|
278 1000 cells/cubic mm
Interval 235.6 to 326.1
|
260 1000 cells/cubic mm
Interval 260.0 to 260.0
|
298 1000 cells/cubic mm
Interval 282.0 to 325.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)-Day 182
|
235.8 1000 cells/cubic mm
Interval 212.8 to 256.0
|
285.5 1000 cells/cubic mm
Interval 219.0 to 352.0
|
231 1000 cells/cubic mm
Interval 231.0 to 231.0
|
317 1000 cells/cubic mm
Interval 317.0 to 317.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Hemoglobin (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Creatinine (mg/dL)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - Clade C MPER - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - Clade C MPER - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5)
|
5 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - SP62 - Month 2.5(V5)
|
5 Participants
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - SP62 - Month 6.5(V7)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - gp41 - Month 2.5(V5)
|
2 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
IgG - gp41 - Month 6.5(V7)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - Clade C MPER - Month 2.5(V5)
|
6.25 Relative luminescence units (RLU)
Interval 3.5 to 16.0
|
4.75 Relative luminescence units (RLU)
Interval 1.75 to 10.38
|
7.75 Relative luminescence units (RLU)
Interval 7.75 to 7.75
|
1 Relative luminescence units (RLU)
Interval 1.0 to 1.0
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - Clade C MPER - Month 6.5(V7)
|
5.38 Relative luminescence units (RLU)
Interval 3.81 to 7.81
|
1 Relative luminescence units (RLU)
Interval 1.0 to 1.0
|
1 Relative luminescence units (RLU)
Interval 1.0 to 1.0
|
1 Relative luminescence units (RLU)
Interval 1.0 to 1.0
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5)
|
8714.25 Relative luminescence units (RLU)
Interval 4366.75 to 17715.0
|
21821.75 Relative luminescence units (RLU)
Interval 10803.62 to 22000.0
|
11 Relative luminescence units (RLU)
Interval 11.0 to 11.0
|
20.5 Relative luminescence units (RLU)
Interval 14.62 to 216.62
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7)
|
17438.62 Relative luminescence units (RLU)
Interval 9718.19 to 22000.0
|
22000 Relative luminescence units (RLU)
Interval 22000.0 to 22000.0
|
11.75 Relative luminescence units (RLU)
Interval 11.75 to 11.75
|
660.5 Relative luminescence units (RLU)
Interval 660.5 to 660.5
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - SP62 - Month 2.5(V5)
|
1057.5 Relative luminescence units (RLU)
Interval 883.75 to 3674.0
|
2593 Relative luminescence units (RLU)
Interval 1052.75 to 5125.5
|
12 Relative luminescence units (RLU)
Interval 12.0 to 12.0
|
1.75 Relative luminescence units (RLU)
Interval 1.38 to 5.88
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - SP62 - Month 6.5(V7)
|
6435.5 Relative luminescence units (RLU)
Interval 937.69 to 13783.44
|
3753.5 Relative luminescence units (RLU)
Interval 3753.5 to 3753.5
|
8.25 Relative luminescence units (RLU)
Interval 8.25 to 8.25
|
1 Relative luminescence units (RLU)
Interval 1.0 to 1.0
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - gp41 - Month 2.5(V5)
|
765.5 Relative luminescence units (RLU)
Interval 716.25 to 4287.75
|
1879.75 Relative luminescence units (RLU)
Interval 993.12 to 5622.38
|
678 Relative luminescence units (RLU)
Interval 678.0 to 678.0
|
384.25 Relative luminescence units (RLU)
Interval 245.5 to 421.75
|
|
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
IgG - gp41 - Month 6.5(V7)
|
5806.5 Relative luminescence units (RLU)
Interval 580.81 to 13653.81
|
2974.25 Relative luminescence units (RLU)
Interval 2974.25 to 2974.25
|
565 Relative luminescence units (RLU)
Interval 565.0 to 565.0
|
139 Relative luminescence units (RLU)
Interval 139.0 to 139.0
|
SECONDARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - HXB2 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - SC422661.8 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - SC422661.8 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - W61D(TCLA).71 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - W61D(TCLA).71 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - W61D(TCLA).71 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - HXB2 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - HXB2 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - SC422661.8 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - SC422661.8 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-80 - W61D(TCLA).71 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
ID-50 - HXB2 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - HXB2 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - HXB2 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - SC422661.8 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - SC422661.8 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - W61D(TCLA).71 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - W61D(TCLA).71 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - HXB2 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - HXB2 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - SC422661.8 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - SC422661.8 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - W61D(TCLA).71 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - W61D(TCLA).71 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
SECONDARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - HXB2 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - HXB2 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - SC422661.8 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - SC422661.8 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - W61D(TCLA).71 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-50 - W61D(TCLA).71 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - HXB2 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - HXB2 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - SC422661.8 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - SC422661.8 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - W61D(TCLA).71 - Month 2.5(V5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
ID-80 - W61D(TCLA).71 - Month 6.5(V7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 2.5(V5) and Month 6.5(V7)Population: Avaiable Data at V5 and V7
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Outcome measures
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 Participants
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 Participants
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 Participants
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - HXB2 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - HXB2 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - SC422661.8 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - SC422661.8 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - W61D(TCLA).71 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-50 - W61D(TCLA).71 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - HXB2 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - HXB2 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - SC422661.8 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - SC422661.8 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - W61D(TCLA).71 - Month 2.5(V5)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
|
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
ID-80 - W61D(TCLA).71 - Month 6.5(V7)
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
NA Relative luminescence units (RLU)
Titers were below the level of detection.
|
Adverse Events
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Control 1: Placebo for MPER-656 mo(0,2,6,12)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 2: Placebo for MPER-656 mo(0,2,6,12)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 participants at risk
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 participants at risk
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 participants at risk
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 participants at risk
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Immune system disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
Other adverse events
| Measure |
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)
n=5 participants at risk
MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.
|
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)
n=15 participants at risk
MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 1: Placebo for MPER-656 mo(0,2,6,12)
n=1 participants at risk
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
Control 2: Placebo for MPER-656 mo(0,2,6,12)
n=3 participants at risk
Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
General disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
13.3%
2/15 • Number of events 2 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
General disorders
Injection site pruritus
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
53.3%
8/15 • Number of events 8 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
26.7%
4/15 • Number of events 4 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
13.3%
2/15 • Number of events 2 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Investigations
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Investigations
Blood pressure increased
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
33.3%
1/3 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Nervous system disorders
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
20.0%
3/15 • Number of events 3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
20.0%
1/5 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/15 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/5 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
6.7%
1/15 • Number of events 1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/1 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
0.00%
0/3 • Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place