Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 HIV-1 infection. It is a monoclonal antibody developed by Merck & Company, Inc. (MRK) for the Infectious Disease therapeutic area. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
V520 is a monoclonal antibody designed to target HIV-1. It is being investigated as a vaccine to prevent or treat HIV-1 infection. The drug is in Phase 1 clinical trials, and its mechanism of action involves the immune system's response to the virus.
V520 is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 1 clinical trials to evaluate the safety and immunogenicity of V520 in healthy adults and individuals with HIV-1 infection.
V520 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with a total enrollment of 610 participants across both studies.
V520 has been studied in two completed Phase 1 trials. NCT00849732 evaluated a 3-dose regimen of the MRKAd5 (Clade B) vaccine in 360 healthy adults. NCT00894114 compared a 1-dose regimen of MRKAd5 HIV-1 Gag vaccine with ALVAC_HIV vaccine in 250 participants with HIV-1 infection.
V520 is the name of the drug product, and it is also referred to as the MRKAd5 HIV-1 Gag vaccine in clinical trial titles. The trials NCT00849732 and NCT00894114 use the MRKAd5 (Clade B) vaccine, which is V520.