Trial Outcomes & Findings for Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023) (NCT NCT00095576)
NCT ID: NCT00095576
Last Updated: 2015-10-06
Results Overview
Number of participants with non-serious AEs with an incidence cut-off of 5% (\>5% in at least one treatment group) and number of participants with \>1 SAE following administration of study vaccine. AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210). Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
TERMINATED
PHASE2
3000 participants
Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
2015-10-06
Participant Flow
3000 participants were enrolled and randomized in the study. However, only 2979 received study vaccination, and are included in the started population. V520-023 was terminated early based on findings at a planned interim analysis and subjects were encouraged to participate in the V520-030 rollover study for additional long term follow up.
Participant milestones
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Overall Study
STARTED
|
1484
|
1495
|
|
Overall Study
VACCINATED AT VISIT 2 (Dose 1)
|
1484
|
1495
|
|
Overall Study
VACCINATED AT VISIT 4 (Dose 2)
|
1426
|
1443
|
|
Overall Study
VACCINATED AT VISIT 7 (Dose 3)
|
1328
|
1361
|
|
Overall Study
COMPLETED
|
9
|
14
|
|
Overall Study
NOT COMPLETED
|
1475
|
1481
|
Reasons for withdrawal
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
233
|
229
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
34
|
47
|
|
Overall Study
Option to switch to a rollover study
|
1097
|
1099
|
|
Overall Study
Site terminated
|
75
|
67
|
|
Overall Study
Subject moved
|
30
|
36
|
Baseline Characteristics
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
Baseline characteristics by cohort
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
n=1484 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
n=1495 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
Total
n=2979 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
30.1 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
565 Participants
n=5 Participants
|
570 Participants
n=7 Participants
|
1135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
919 Participants
n=5 Participants
|
925 Participants
n=7 Participants
|
1844 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)Number of participants with non-serious AEs with an incidence cut-off of 5% (\>5% in at least one treatment group) and number of participants with \>1 SAE following administration of study vaccine. AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210). Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
Outcome measures
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
n=1484 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
n=1495 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Number of Participants With Clinical Adverse Experiences
With non-serious adverse events (NSAE)
|
1221 Participants
|
946 Participants
|
|
Number of Participants With Clinical Adverse Experiences
With no non-serious adverse events
|
263 Participants
|
549 Participants
|
|
Number of Participants With Clinical Adverse Experiences
With serious adverse events
|
19 Participants
|
17 Participants
|
|
Number of Participants With Clinical Adverse Experiences
With no serious adverse events
|
1465 Participants
|
1478 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 208Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring \> 5% in at least one treatment group) following administration of the first dose of study vaccine. 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 14 days after any vaccine dose.
Outcome measures
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
n=1484 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
n=1495 Participants
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Number of Participants With Laboratory Adverse Experiences
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)Population: An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.
The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)Population: An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.
Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
Outcome measures
Outcome data not reported
Adverse Events
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
Placebo
Serious adverse events
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
n=1484 participants at risk
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
n=1495 participants at risk
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia aggravated
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Congenital, familial and genetic disorders
Congenital cardiovascular anomaly
|
0.00%
0/1484
|
0.13%
2/1495 • Number of events 2
|
|
Congenital, familial and genetic disorders
Hypoplastic left heart syndrome
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Congenital, familial and genetic disorders
Unspecified congenital anomaly of heart
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Gastrointestinal disorders
Acute diarrhoea
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
General disorders
Fever
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
General disorders
Rigors
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Infections and infestations
Shunt infection
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Infections and infestations
Staphylococcal abscess
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Infections and infestations
Vulval abscess
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.07%
1/1484 • Number of events 1
|
0.07%
1/1495 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Musculoskeletal and connective tissue disorders
Slipped disc
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine fibroids
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Psychiatric disorders
Depression
|
0.07%
1/1484 • Number of events 1
|
0.07%
1/1495 • Number of events 1
|
|
Psychiatric disorders
Depression aggravated
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Psychiatric disorders
Depressive episode
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Psychiatric disorders
Manic episode
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Psychiatric disorders
Polysubstance dependence
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1484
|
0.07%
1/1495 • Number of events 1
|
|
Renal and urinary disorders
Kidney stone
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
|
Vascular disorders
Hypertension
|
0.07%
1/1484 • Number of events 1
|
0.00%
0/1495
|
Other adverse events
| Measure |
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef
n=1484 participants at risk
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
|
Placebo
n=1495 participants at risk
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
156/1484 • Number of events 195
|
9.9%
148/1495 • Number of events 182
|
|
Gastrointestinal disorders
Nausea
|
6.3%
94/1484 • Number of events 114
|
5.0%
75/1495 • Number of events 87
|
|
General disorders
Fatigue
|
11.5%
170/1484 • Number of events 218
|
8.0%
120/1495 • Number of events 149
|
|
General disorders
Fever
|
25.3%
376/1484 • Number of events 631
|
20.7%
309/1495 • Number of events 548
|
|
General disorders
General body pain
|
5.1%
76/1484 • Number of events 98
|
1.5%
23/1495 • Number of events 26
|
|
General disorders
Injection site erythema
|
21.4%
317/1484 • Number of events 448
|
9.6%
143/1495 • Number of events 197
|
|
General disorders
Injection site pain
|
64.8%
961/1484 • Number of events 1862
|
31.8%
475/1495 • Number of events 702
|
|
General disorders
Injection site swelling
|
22.7%
337/1484 • Number of events 511
|
7.7%
115/1495 • Number of events 149
|
|
General disorders
Injection site tenderness
|
18.3%
271/1484 • Number of events 374
|
5.4%
81/1495 • Number of events 92
|
|
Nervous system disorders
Headache
|
31.1%
461/1484 • Number of events 734
|
26.4%
394/1495 • Number of events 631
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
83/1484 • Number of events 96
|
5.6%
83/1495 • Number of events 90
|
Additional Information
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