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V520 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | V520 (1x10\^9 vp/d) |
| 2 | EXPERIMENTAL | V520 (1x10\^10 vp/d) |
| 3 | PLACEBO_COMPARATOR | Placebo to V520 |
| 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 | Intentionally Blank |
| Comparator: V520 (1x10^9 vp/d) | BIOLOGICAL | 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^9 vp/d given at Day 1, Week 4, and Week 26 |
| Comparator: V520 (1x10^10 vp/d) | BIOLOGICAL | 1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^10 vp/d given at Day 1, Week 4, and Week 26 |
| Comparator: Placebo | BIOLOGICAL | Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26 |
| Comparator: ALVAC-HIV vaccine | BIOLOGICAL | A single dose 0.1 intramuscular injection |
Inclusion Criteria: * Subject is in good general health * Subject tests negative for Hepatitis B, Hepatitis C, and HIV * Subjects of reproductive potential agree to use an accepted method of birth control through the entire study Exclusion Criteria: * Subject has a recent history of fever at time...
V520 is an investigational vaccine being studied for the prevention of HIV-1 infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is designed to elicit an immune response against HIV-1, with clinical trials evaluating its safety, tolerability, and immunogenicity in healthy adults.
V520 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult volunteers as part of its HIV-1 prevention research program.
V520 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been completed, and the vaccine remains under investigation for its potential use in preventing HIV-1 infection.
V520 has been evaluated in two completed Phase 1 clinical trials. The first, NCT00849732, was a dose-escalating study of a 3-dose regimen of the MRKAd5 (Clade B) vaccine in 360 healthy adults. The second, NCT00894114, compared a 1-dose regimen of MRKAd5 HIV-1 Gag vaccine with the ALVAC_HIV vaccine in 250 participants.
V520 is the name used in clinical trials for a vaccine developed by Merck. In the trial NCT00894114, it is referred to as the MRKAd5 HIV-1 Gag vaccine, indicating that V520 is an adenovirus serotype 5 vector-based vaccine expressing HIV-1 Gag. The vaccine is being studied for its ability to induce immune responses against HIV-1.