Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00095576 |
|
Recruitment Status :
Terminated
First Posted : November 8, 2004
Results First Posted : August 15, 2011
Last Update Posted : October 6, 2015
|
Sponsor:
Merck Sharp & Dohme LLC
Collaborator:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, 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 |
| Enrollment | 3000 |
Participant Flow
| Recruitment Details |
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 |
| Arm/Group Title | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
 Arm/Group Description |
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. | 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. |
| Period Title: Overall Study | ||
| 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 |
| Reason Not Completed | ||
| 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
|
||
Baseline Characteristics
| Arm/Group Title | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
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. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 1484 | 1495 | 2979 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 1484 participants | 1495 participants | 2979 participants | |
| 29.9 (7.8) | 30.2 (8.13) | 30.1 (7.97) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 1484 participants | 1495 participants | 2979 participants | |
| Female |
565 38.1%
|
570 38.1%
|
1135 38.1%
|
|
| Male |
919 61.9%
|
925 61.9%
|
1844 61.9%
|
|
Outcome Measures
Adverse Events
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.
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.
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.
Results Point of Contact
| Name/Title: | Senior Vice President, Global Clinical Development |
| Organization: | Merck, Sharp & Dohme |
| EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT00095576 |
| Obsolete Identifiers: | NCT00770549 |
| Other Study ID Numbers: |
V520-023 2004_091 |
| First Submitted: | November 5, 2004 |
| First Posted: | November 8, 2004 |
| Results First Submitted: | July 20, 2011 |
| Results First Posted: | August 15, 2011 |
| Last Update Posted: | October 6, 2015 |