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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857311 | MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED) | PHASE1 | COMPLETED | 17 | — | — | May 1, 2004 | May 1, 2010 | Aug 25, 2015 | - | — |
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 |