Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00894114 | A Study of Safety, Tolerability and Immunogenicity of a 1-Dose Regimen of MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC_HIV Vaccine (V520-019) | PHASE1 | COMPLETED | 250 | — | — | May 1, 2003 | Jun 1, 2009 | May 28, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Stratum 1 | OTHER | Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine |
| Stratum 2 | EXPERIMENTAL | Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
| Stratum 3 | EXPERIMENTAL | Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
| Stratum 4 | EXPERIMENTAL | High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine |
| Name | Type | Description |
|---|---|---|
| V520 | BIOLOGICAL | MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection |
| Comparator: ALVAC-HIV vaccine | BIOLOGICAL | A single dose 0.1 intramuscular injection |
Inclusion Criteria: * Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation * Subject is in good general health * Subject is not infected with HIV * Subject agrees not to donate blood during the first 52 we...