Trial Outcomes & Findings for A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016) (NCT NCT00849680)
NCT ID: NCT00849680
Last Updated: 2015-02-02
Results Overview
Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs. Systemic and Laboratory AEs include any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
317 participants
Primary outcome timeframe
up to 260 weeks after first vaccination
Results posted on
2015-02-02
Participant Flow
317 participants were randomized. 2 did not receive any study medication. Therefore, the safety population was 315.
Participant milestones
| Measure |
Placebo
2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)
2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
13
|
42
|
42
|
42
|
42
|
78
|
31
|
|
Overall Study
COMPLETED
|
16
|
10
|
27
|
28
|
32
|
27
|
61
|
23
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
15
|
14
|
10
|
15
|
17
|
8
|
Reasons for withdrawal
| Measure |
Placebo
2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)
2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
12
|
11
|
8
|
11
|
12
|
5
|
|
Overall Study
Subject moved
|
1
|
0
|
3
|
1
|
0
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
2
|
2
|
1
|
1
|
|
Overall Study
Subject unable to comply with protocol
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)
n=13 Participants
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)
n=78 Participants
2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
n=31 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
32.4 Years
n=99 Participants
|
34.3 Years
n=107 Participants
|
33.2 Years
n=206 Participants
|
32.6 Years
n=7 Participants
|
33.3 Years
n=31 Participants
|
34.0 Years
n=30 Participants
|
35.7 Years
n=3 Participants
|
34.8 Years
n=6 Participants
|
34.0 Years
n=114 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
149 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
47 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
168 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
13 participants
n=107 Participants
|
42 participants
n=206 Participants
|
42 participants
n=7 Participants
|
42 participants
n=31 Participants
|
42 participants
n=30 Participants
|
78 participants
n=3 Participants
|
31 participants
n=6 Participants
|
317 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: up to 260 weeks after first vaccinationAdverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs. Systemic and Laboratory AEs include any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.
Outcome measures
| Measure |
Placebo
n=27 Participants
2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)
n=13 Participants
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)
n=41 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)
n=41 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)
n=78 Participants
2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
n=31 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Experiences
With serious injection site AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Experiences
With Injection site AEs
|
6 Participants
|
9 Participants
|
17 Participants
|
18 Participants
|
22 Participants
|
23 Participants
|
57 Participants
|
29 Participants
|
|
Number of Participants With Adverse Experiences
With non-serious systemic AEs (NSAE)
|
20 Participants
|
13 Participants
|
36 Participants
|
33 Participants
|
35 Participants
|
37 Participants
|
68 Participants
|
28 Participants
|
|
Number of Participants With Adverse Experiences
With serious systemic AEs
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 260 weeks after first vaccinationPopulation: Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included.
Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 29 days after any vaccine dose.
Outcome measures
| Measure |
Placebo
n=25 Participants
2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)
n=13 Participants
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)
n=41 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)
n=42 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)
n=41 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)
n=78 Participants
2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly.
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
n=31 Participants
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Adverse Experiences
With serious laboratory AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Adverse Experiences
With non-serious laboratory AEs
|
10 Participants
|
5 Participants
|
12 Participants
|
6 Participants
|
12 Participants
|
17 Participants
|
29 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after booster injectionPopulation: No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.
Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10\^6 peripheral blood mononuclear cells (SFC per million PBMCs).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 weeks after booster injectionPopulation: No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.
Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10\^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)
n=13 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)
n=41 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)
n=78 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)
n=31 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
General disorders
Chest pain
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Hepatobiliary disorders
Cholecystitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Appendicitis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Kidney infection
|
0.00%
0/26
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/26
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Electrocardiogram change
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
3.2%
1/31 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Syncope
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Psychiatric disorders
Depression
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
2.6%
2/78 • Number of events 2
|
0.00%
0/31
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
2.6%
2/78 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 2
|
0.00%
0/78
|
0.00%
0/31
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
|
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)
n=13 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)
n=41 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)
n=42 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)
n=78 participants at risk
|
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)
n=31 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
2/26 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 2
|
4.8%
2/42 • Number of events 10
|
2.4%
1/42 • Number of events 1
|
1.3%
1/78 • Number of events 1
|
6.5%
2/31 • Number of events 4
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear pain
|
3.8%
1/26 • Number of events 1
|
15.4%
2/13 • Number of events 3
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
2.4%
1/42 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
3/26 • Number of events 5
|
23.1%
3/13 • Number of events 3
|
17.1%
7/41 • Number of events 7
|
16.7%
7/42 • Number of events 8
|
11.9%
5/42 • Number of events 6
|
23.8%
10/42 • Number of events 17
|
14.1%
11/78 • Number of events 12
|
22.6%
7/31 • Number of events 11
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26
|
15.4%
2/13 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
17.9%
14/78 • Number of events 17
|
12.9%
4/31 • Number of events 4
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
5.1%
4/78 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Chills
|
11.5%
3/26 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 2
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
23.1%
18/78 • Number of events 21
|
29.0%
9/31 • Number of events 12
|
|
General disorders
Fatigue
|
11.5%
3/26 • Number of events 3
|
30.8%
4/13 • Number of events 6
|
12.2%
5/41 • Number of events 8
|
16.7%
7/42 • Number of events 10
|
14.3%
6/42 • Number of events 8
|
28.6%
12/42 • Number of events 14
|
25.6%
20/78 • Number of events 23
|
38.7%
12/31 • Number of events 18
|
|
General disorders
Feeling of body temperature change
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
5.1%
4/78 • Number of events 4
|
0.00%
0/31
|
|
General disorders
Injection site erythema
|
15.4%
4/26 • Number of events 6
|
30.8%
4/13 • Number of events 5
|
14.6%
6/41 • Number of events 6
|
14.3%
6/42 • Number of events 6
|
16.7%
7/42 • Number of events 9
|
19.0%
8/42 • Number of events 10
|
19.2%
15/78 • Number of events 19
|
35.5%
11/31 • Number of events 14
|
|
General disorders
Injection site haematoma
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
0.00%
0/78
|
0.00%
0/31
|
|
General disorders
Injection site pain
|
19.2%
5/26 • Number of events 9
|
61.5%
8/13 • Number of events 19
|
31.7%
13/41 • Number of events 18
|
31.0%
13/42 • Number of events 20
|
50.0%
21/42 • Number of events 40
|
52.4%
22/42 • Number of events 42
|
71.8%
56/78 • Number of events 114
|
93.5%
29/31 • Number of events 68
|
|
General disorders
Injection site pruritus
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
7.3%
3/41 • Number of events 3
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Injection site swelling
|
3.8%
1/26 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
0.00%
0/41
|
9.5%
4/42 • Number of events 4
|
11.9%
5/42 • Number of events 6
|
19.0%
8/42 • Number of events 9
|
21.8%
17/78 • Number of events 22
|
32.3%
10/31 • Number of events 14
|
|
General disorders
Malaise
|
0.00%
0/26
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
5.1%
4/78 • Number of events 6
|
6.5%
2/31 • Number of events 4
|
|
General disorders
Pain
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
7.1%
3/42 • Number of events 4
|
0.00%
0/42
|
9.5%
4/42 • Number of events 5
|
12.8%
10/78 • Number of events 13
|
12.9%
4/31 • Number of events 5
|
|
General disorders
Pyrexia
|
7.7%
2/26 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
4.8%
2/42 • Number of events 3
|
14.3%
6/42 • Number of events 7
|
11.9%
5/42 • Number of events 7
|
26.9%
21/78 • Number of events 30
|
35.5%
11/31 • Number of events 19
|
|
Infections and infestations
Abscess limb
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
1.3%
1/78 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26
|
15.4%
2/13 • Number of events 2
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Furuncle
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Localised infection
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
7.1%
3/42 • Number of events 3
|
7.1%
3/42 • Number of events 3
|
5.1%
4/78 • Number of events 4
|
6.5%
2/31 • Number of events 3
|
|
Infections and infestations
Pharyngitis
|
3.8%
1/26 • Number of events 2
|
0.00%
0/13
|
4.9%
2/41 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
5.1%
4/78 • Number of events 5
|
0.00%
0/31
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Rash pustular
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
3.2%
1/31 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
4.9%
2/41 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
5.1%
4/78 • Number of events 4
|
0.00%
0/31
|
|
Infections and infestations
Skin infection
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
4/26 • Number of events 5
|
23.1%
3/13 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
14.3%
6/42 • Number of events 7
|
11.9%
5/42 • Number of events 5
|
9.5%
4/42 • Number of events 5
|
16.7%
13/78 • Number of events 16
|
6.5%
2/31 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
2.6%
2/78 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
10.3%
8/78 • Number of events 10
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
7.3%
3/41 • Number of events 3
|
0.00%
0/42
|
7.1%
3/42 • Number of events 5
|
2.4%
1/42 • Number of events 1
|
3.8%
3/78 • Number of events 5
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Bacteria urine identified
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
4.8%
2/42 • Number of events 3
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
Blood amylase increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 4
|
0.00%
0/42
|
0.00%
0/42
|
2.6%
2/78 • Number of events 4
|
3.2%
1/31 • Number of events 5
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
9.5%
4/42 • Number of events 4
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
Blood creatine phosphokinase increased
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
4.9%
2/41 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
9.5%
4/42 • Number of events 8
|
5.1%
4/78 • Number of events 8
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Blood urine present
|
11.5%
3/26 • Number of events 6
|
7.7%
1/13 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42 • Number of events 4
|
2.6%
2/78 • Number of events 7
|
0.00%
0/31
|
|
Investigations
Body temperature increased
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
6.5%
2/31 • Number of events 2
|
|
Investigations
C-reactive protein increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
3.2%
1/31 • Number of events 2
|
|
Investigations
Eosinophil count increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.00%
0/26
|
0.00%
0/13
|
2.4%
1/41 • Number of events 1
|
4.8%
2/42 • Number of events 3
|
0.00%
0/42
|
2.4%
1/42 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
2.4%
1/41 • Number of events 2
|
4.8%
2/42 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
2.4%
1/42 • Number of events 2
|
2.6%
2/78 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 2
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
6.4%
5/78 • Number of events 6
|
9.7%
3/31 • Number of events 4
|
|
Investigations
Neutrophil count increased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
Protein urine present
|
7.7%
2/26 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
4.9%
2/41 • Number of events 3
|
0.00%
0/42
|
4.8%
2/42 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Red blood cells urine positive
|
19.2%
5/26 • Number of events 6
|
0.00%
0/13
|
2.4%
1/41 • Number of events 2
|
0.00%
0/42
|
0.00%
0/42
|
9.5%
4/42 • Number of events 4
|
10.3%
8/78 • Number of events 16
|
0.00%
0/31
|
|
Investigations
Urinary sediment present
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
4.8%
2/42 • Number of events 4
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
White blood cell count decreased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
0.00%
0/42
|
5.1%
4/78 • Number of events 4
|
6.5%
2/31 • Number of events 3
|
|
Investigations
White blood cell count increased
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
0.00%
0/78
|
0.00%
0/31
|
|
Investigations
White blood cells urine positive
|
15.4%
4/26 • Number of events 7
|
15.4%
2/13 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
4.8%
2/42 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
0.00%
0/42
|
9.5%
4/42 • Number of events 6
|
3.8%
3/78 • Number of events 3
|
9.7%
3/31 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 2
|
15.4%
2/13 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
4.8%
2/42 • Number of events 5
|
7.1%
3/42 • Number of events 3
|
7.1%
3/42 • Number of events 3
|
3.8%
3/78 • Number of events 3
|
9.7%
3/31 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/26
|
0.00%
0/13
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 2
|
9.8%
4/41 • Number of events 4
|
9.5%
4/42 • Number of events 5
|
14.3%
6/42 • Number of events 18
|
7.1%
3/42 • Number of events 4
|
17.9%
14/78 • Number of events 19
|
25.8%
8/31 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 4
|
0.00%
0/78
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 2
|
5.1%
4/78 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Headache
|
46.2%
12/26 • Number of events 24
|
46.2%
6/13 • Number of events 12
|
24.4%
10/41 • Number of events 25
|
31.0%
13/42 • Number of events 17
|
31.0%
13/42 • Number of events 26
|
28.6%
12/42 • Number of events 19
|
44.9%
35/78 • Number of events 69
|
45.2%
14/31 • Number of events 23
|
|
Nervous system disorders
Migraine
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Psychiatric disorders
Agitation
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26
|
0.00%
0/13
|
7.3%
3/41 • Number of events 5
|
2.4%
1/42 • Number of events 4
|
9.5%
4/42 • Number of events 7
|
0.00%
0/42
|
7.7%
6/78 • Number of events 6
|
0.00%
0/31
|
|
Renal and urinary disorders
Dysuria
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
2.6%
2/78 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4
|
0.00%
0/13
|
12.2%
5/41 • Number of events 5
|
4.8%
2/42 • Number of events 2
|
19.0%
8/42 • Number of events 9
|
14.3%
6/42 • Number of events 6
|
3.8%
3/78 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
1.3%
1/78 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
14.3%
6/42 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
12.8%
10/78 • Number of events 12
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
23.1%
6/26 • Number of events 8
|
15.4%
2/13 • Number of events 6
|
19.5%
8/41 • Number of events 11
|
11.9%
5/42 • Number of events 5
|
28.6%
12/42 • Number of events 18
|
23.8%
10/42 • Number of events 16
|
16.7%
13/78 • Number of events 16
|
9.7%
3/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
2/26 • Number of events 2
|
0.00%
0/13
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
3.8%
3/78 • Number of events 3
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/26
|
15.4%
2/13 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
2.6%
2/78 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/78
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26
|
15.4%
2/13 • Number of events 3
|
0.00%
0/41
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
3.8%
3/78 • Number of events 4
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
4.9%
2/41 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
1.3%
1/78 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Flushing
|
7.7%
2/26 • Number of events 2
|
0.00%
0/13
|
0.00%
0/41
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/78
|
0.00%
0/31
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee As this study is part of a multicenter trial, publications derived from this study should include input from the principal investigator, his/her colleagues, the other investigators in this trial, and SPONSOR personnel. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER