Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention |
Conditions: |
AIDS HIV Infections |
Interventions: |
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) Drug: Comparator: placebo |
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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No text entered. |
Reporting Groups
Description | |
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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. |
Participant Flow: Overall Study
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo | |
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STARTED | 1484 | 1495 |
VACCINATED AT VISIT 2 (Dose 1) | 1484 | 1495 |
VACCINATED AT VISIT 4 (Dose 2) | 1426 | 1443 |
VACCINATED AT VISIT 7 (Dose 3) | 1328 | 1361 |
COMPLETED | 9 [1] | 14 [1] |
NOT COMPLETED | 1475 | 1481 |
Adverse Event | 5 | 3 |
Lost to Follow-up | 233 | 229 |
Protocol Violation | 1 | 0 |
Withdrawal by Subject | 34 | 47 |
Option to switch to a rollover study | 1097 | 1099 |
Site terminated | 75 | 67 |
Subject moved | 30 | 36 |
[1] | Subjects not completing entire study were eligible for observational long term follow up in V520-030 |
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Baseline Characteristics
Reporting Groups
Description | |
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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. |
Baseline Measures
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo | Total | |
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Number of Participants
[units: participants] |
1484 | 1495 | 2979 |
Age
[units: years] Mean ± Standard Deviation |
29.9 ± 7.8 | 30.2 ± 8.13 | 30.1 ± 7.97 |
Gender
[units: participants] |
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Female | 565 | 570 | 1135 |
Male | 919 | 925 | 1844 |
Outcome Measures
1. Primary: | Number of Participants With Clinical Adverse Experiences [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ] |
2. Primary: | Number of Participants With Laboratory Adverse Experiences [ Time Frame: Day 1 to Week 208 ] |
3. Primary: | Number of Participants With HIV-1 Infections [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ] |
4. Primary: | HIV-1 Viral Load in Infected Participants [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ] |
More Information
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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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. |
Results Point of Contact:
Organization: Merck, Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com
Publications:
Publications automatically indexed to this study:
Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
ClinicalTrials.gov Identifier: | NCT00095576 History of Changes |
Obsolete Identifiers: | NCT00770549 |
Other Study ID Numbers: | V520-023, 2004_091 |
Study First Received: | November 5, 2004 |
Results First Received: | July 20, 2011 |
Last Updated: | August 25, 2011 |
Health Authority: | United States: Food and Drug Administration |