Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MRKAd5 HIV-1 gag vaccine · 1 trial · 1 indication
Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.
| Arm | Type | Description |
|---|---|---|
| MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose | EXPERIMENTAL | Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. |
| MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose | EXPERIMENTAL | Participants were to be administered MRKAd5 HIV-1 gag 1x10\^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10\^10 vp/dose. |
| Placebo | EXPERIMENTAL | Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. |
| Open Label Tetanus and Diptheria Toxoids Adsorbed | SHAM_COMPARATOR | Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group. |
| Name | Type | Description |
|---|---|---|
| MRKAd5 HIV-1 gag vaccine (V520) | BIOLOGICAL | 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26 |
| Comparator: Placebo | BIOLOGICAL | 1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26 |
| Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed | BIOLOGICAL | 0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only |
Inclusion Criteria: * Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study Exclusion Criteria: * Subject weighs less than 110 lbs. * Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
MRKAd5 HIV-1 gag vaccine is an investigational vaccine being studied for use in Hepatitis C. It is a Phase 1 candidate developed by Merck & Company, Inc. (MRK). The vaccine was evaluated in a completed clinical trial involving 17 participants with chronic Hepatitis C.
MRKAd5 HIV-1 gag vaccine is designed to target the HIV-1 gag protein. It uses an adenovirus serotype 5 (Ad5) vector to deliver the gag antigen. The vaccine is being investigated for its potential immune effects in the context of Hepatitis C infection.
MRKAd5 HIV-1 gag vaccine is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. The vaccine is currently in Phase 1 clinical development.
MRKAd5 HIV-1 gag vaccine is in Phase 1 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed for this candidate.
MRKAd5 HIV-1 gag vaccine was studied in clinical trial NCT00857311, titled 'MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022)'. This Phase 1 trial was completed and enrolled 17 participants with Hepatitis C. The trial was randomized, double-blind, and sham-controlled.