Trial Outcomes & Findings for Therapeutic Vaccine for HIV (NCT NCT01859325)
NCT ID: NCT01859325
Last Updated: 2020-03-03
Results Overview
The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are: At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
48 weeks
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
Excluded
Participants not meeting inclusion criteria or declined to participate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
2
|
|
Overall Study
COMPLETED
|
12
|
12
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Vaccine for HIV
Baseline characteristics by cohort
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
n=15 Participants
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
n=16 Participants
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: All subjects who received vaccine or placebo
The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are: At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines.
Outcome measures
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
n=14 Participants
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
n=15 Participants
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
|---|---|---|
|
The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection.
|
0 Related Adverse Events
|
0 Related Adverse Events
|
SECONDARY outcome
Timeframe: 72 weeksPopulation: All subjects who received vaccine or placebo
The difference in HIV-1 viral load at the end of the ATI between the vaccine and placebo groups. Levels of plasma viremia in the vaccine and placebo groups were compared using the Wilcoxon rank sum test at the end of treatment interruption periods to determine the antiviral efficacy of the therapeutic vaccine regimen. The limit of detection of plasma viremia was 40 copies/ml of HIV RNA.
Outcome measures
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
n=14 Participants
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
n=15 Participants
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
|---|---|---|
|
HIV-1 Viral Load Following Antiretroviral Treatment Interruption (ATI).
|
4932 copies/ml
Interval 513.0 to 22577.0
|
3170 copies/ml
Interval 467.0 to 7025.0
|
Adverse Events
HIV-Mag/IL-12 & rVSV Vaccine
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
n=15 participants at risk
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
n=16 participants at risk
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Vascular disorders
Thrombosis
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
Other adverse events
| Measure |
HIV-Mag/IL-12 & rVSV Vaccine
n=15 participants at risk
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
|
Placebo
n=16 participants at risk
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • 96 weeks
|
25.0%
4/16 • 96 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
General disorders
Chills
|
33.3%
5/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
General disorders
Fatigue
|
73.3%
11/15 • 96 weeks
|
43.8%
7/16 • 96 weeks
|
|
General disorders
Injection site erythema
|
13.3%
2/15 • 96 weeks
|
31.2%
5/16 • 96 weeks
|
|
General disorders
Injection site pain
|
100.0%
15/15 • 96 weeks
|
93.8%
15/16 • 96 weeks
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • 96 weeks
|
18.8%
3/16 • 96 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
General disorders
Pyrexia
|
13.3%
2/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Acute sinusitis
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Diarrhoea infectious
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Infections and infestations
Infection
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Osteomyelitis
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Staphylococcal infection
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Tinea versicolour
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • 96 weeks
|
31.2%
5/16 • 96 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • 96 weeks
|
18.8%
3/16 • 96 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
6.7%
1/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
3/15 • 96 weeks
|
25.0%
4/16 • 96 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Investigations
Blood bicarbonate abnormal
|
6.7%
1/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • 96 weeks
|
18.8%
3/16 • 96 weeks
|
|
Investigations
C-reactive protein increased
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
40.0%
6/15 • 96 weeks
|
37.5%
6/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.7%
1/15 • 96 weeks
|
25.0%
4/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.3%
2/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
3/15 • 96 weeks
|
25.0%
4/16 • 96 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
5/15 • 96 weeks
|
31.2%
5/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
10/15 • 96 weeks
|
43.8%
7/16 • 96 weeks
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • 96 weeks
|
31.2%
5/16 • 96 weeks
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • 96 weeks
|
18.8%
3/16 • 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
2/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • 96 weeks
|
12.5%
2/16 • 96 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
|
Surgical and medical procedures
Toe amputation
|
6.7%
1/15 • 96 weeks
|
0.00%
0/16 • 96 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • 96 weeks
|
6.2%
1/16 • 96 weeks
|
Additional Information
Sneller, Michael
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 0491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place