Trial · NCT00095576
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
NCT00095576, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2011-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023). Trials, record NCT00095576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095576
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
- NCT number
- NCT00095576
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3,000 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- AIDS, HIV Infections
- Interventions
- Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose), Comparator: placebo
- First posted
- 2004-11-08
- Last updated
- 2015-10-06
- Results first posted
- 2011-08-15
- Limitations and caveats
The DSMB (Data \& Safety Monitoring Board) reviewed interim data which demonstrated that the investigational vaccine was not effective, and all vaccinations were halted. Long term follow up was available for participants in V520-030.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Adverse Experiences | 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. |
| Primary | Number of Participants With Laboratory Adverse Experiences | Day 1 to Week 208 | Number 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. |
| Primary | Number of Participants With HIV-1 Infections | Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) | 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. |
| Primary | HIV-1 Viral Load in Infected Participants | Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Adverse Experiences | Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) | Participants | NUMBER | |
| PRIMARY | Number of Participants With Laboratory Adverse Experiences | Day 1 to Week 208 | Participants | NUMBER | |
| PRIMARY | Number of Participants With HIV-1 Infections | Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) | 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. | ||
| PRIMARY | HIV-1 Viral Load in Infected Participants | Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) | 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. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Adverse Experiences | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | With non-serious adverse events (NSAE) | 1221 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Placebo | With non-serious adverse events (NSAE) | 946 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | With no non-serious adverse events | 263 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Placebo | With no non-serious adverse events | 549 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | With serious adverse events | 19 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Placebo | With serious adverse events | 17 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | With no serious adverse events | 1465 | Participants | |
| Number of Participants With Clinical Adverse Experiences | Placebo | With no serious adverse events | 1478 | Participants | |
| Number of Participants With Laboratory Adverse Experiences | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 0 | Participants | ||
| Number of Participants With Laboratory Adverse Experiences | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 1,484 | |
| Overall Study | STARTED | Placebo | 1,495 | |
| Overall Study | VACCINATED AT VISIT 2 (Dose 1) | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 1,484 | |
| Overall Study | VACCINATED AT VISIT 2 (Dose 1) | Placebo | 1,495 | |
| Overall Study | VACCINATED AT VISIT 4 (Dose 2) | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 1,426 | |
| Overall Study | VACCINATED AT VISIT 4 (Dose 2) | Placebo | 1,443 | |
| Overall Study | VACCINATED AT VISIT 7 (Dose 3) | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 1,328 | |
| Overall Study | VACCINATED AT VISIT 7 (Dose 3) | Placebo | 1,361 | |
| Overall Study | COMPLETED | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 9 | |
| Overall Study | COMPLETED | Placebo | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 156 | 1,484 | 195 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 148 | 1,495 | 182 |
| other | Nausea | Gastrointestinal disorders | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 94 | 1,484 | 114 |
| other | Nausea | Gastrointestinal disorders | Placebo | 75 | 1,495 | 87 |
| other | Fatigue | General disorders | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 170 | 1,484 | 218 |
| other | Fatigue | General disorders | Placebo | 120 | 1,495 | 149 |
| other | Fever | General disorders | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 376 | 1,484 | 631 |
| other | Fever | General disorders | Placebo | 309 | 1,495 | 548 |
| other | General body pain | General disorders | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 76 | 1,484 | 98 |
| other | General body pain | General disorders | Placebo | 23 | 1,495 | 26 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 1,221 | 1,484 |
| Total, other adverse events | Placebo | 946 | 1,495 |
| Total, serious adverse events | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | 19 | 1,484 |
| Total, serious adverse events | Placebo | 17 | 1,495 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trivalent MRKAd5 HIV-1 Gag/Pol/Nef vs Placebo: Number of Participants With Laboratory Adverse Experiences | Trial comparisons |
| Trivalent MRKAd5 HIV-1 Gag/Pol/Nef vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00095576
GET https://conductscience.org/api/trials/v1/NCT00095576/events?page=2