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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01989533 | Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers | PHASE1 | COMPLETED | 62 | — | — | Nov 19, 2013 | Apr 8, 2019 | Dec 17, 2019 | 1 | United States |
Safety
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | Placebo controlled (blinded) |
| B | ACTIVE_COMPARATOR | Intranasal Randomized |
| C | EXPERIMENTAL | Oral Open label |
| D | EXPERIMENTAL | Intranasal Open Label |
| Name | Type | Description |
|---|---|---|
| Ad4-mgag | BIOLOGICAL | Ad4 live virus vaccine with an HIV insert |
| Ad4-EnvC150 | BIOLOGICAL | Ad4 live virus vaccine with an HIV insert |
| gp 120 Protein Boost | BIOLOGICAL | HIV protein boost |
* INCLUSION CRITERIA: All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria: 1. Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts. 2. Negative FDA-approved HIV test. 3. Able to provide proof of identit...