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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01215149 | Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults | PHASE1 | COMPLETED | 218 | — | — | Oct 1, 2010 | Dec 1, 2012 | Dec 17, 2012 | 6 | United States, Kenya +2 |
To evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV administered in heterologous and homologous prime-boost regimens.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 6. Vaccine:Placebo=10:3 |
| Group B | EXPERIMENTAL | Ad35-ENVA at Month 0 followed by Ad26.ENVA.01 at Month 6. Vaccine:Placebo=10:3 |
| Group C | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=10:3 |
| Group D | EXPERIMENTAL | Ad35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=10:3 |
| Group E | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4 |
| Group F | EXPERIMENTAL | Ad35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4 |
| Group G | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4 |
| Group H | EXPERIMENTAL | Ad35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4 |
| Group I | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4 |
| Group J | EXPERIMENTAL | Ad35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4 |
| Group K | EXPERIMENTAL | Ad26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4 |
| Group L | EXPERIMENTAL | Ad35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4 |
| Name | Type | Description |
|---|---|---|
| Ad35-ENV vaccine | BIOLOGICAL | Recombinant adenovirus serotype 35 vector vaccine 5x10\^10 vp, delivered IM |
| Ad26.ENVA.01 vaccine | BIOLOGICAL | Recombinant adenovirus serotype 26 vector vaccine, 5x10\^10 vp delivered IM |
| Placebo Control | BIOLOGICAL | Colorless 10mm Tris/HCl buffer |
Inclusion Criteria: * Healthy male or female, as assessed by a medical history, physical exam, and laboratory tests; * At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination; * Willing to comply with the requirements of the protoco...