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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04364035 | Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients | PHASE2 | COMPLETED | 50 | — | — | Feb 20, 2020 | Dec 16, 2022 | Jul 27, 2023 | 9 | Spain |
Proportion of participants developing solicited Grade 3 or 4 local reactions in the 7-day period following administration of IMPs during Period 1
Proportion of participants developing solicited Grade 3 or 4 systemic reactions in the 7-day period following administration of IMPs during Period 1
Proportion of participants developing treatment-emergent SAEs during Period 1
| Arm | Type | Description |
|---|---|---|
| CCMM+GS-9620 | EXPERIMENTAL | ChAdOx1.HTI 2 doses, MVA.HTI 2 doses, GS-9620 10 doses. |
| PLACEBO | PLACEBO_COMPARATOR | ChAdOx1.HTI placebo 2 doses, MVA.HTI placebo 2 doses, GS-9620, placebo 10 doses. |
| Name | Type | Description |
|---|---|---|
| ChAdOx1.HTI | BIOLOGICAL | ChAdOx1.HTI at week 0 and week 12; Vaccine delivered as one 0. 5 mL IM injection |
| MVA.HTI | BIOLOGICAL | MVA.HTI at week 24 and week 36; Vaccine delivered as one 0. 5 mL IM injection |
| GS-9620 | DRUG | GS-9620 at week 26,28,30,32,34,38,40,42,44 and 46 Unit-dose tablet, delivered as two 3-mg tablets |
| Placebo | BIOLOGICAL | Saline placebo delivered as one 0. 5 mL IM injection |
| Placebo Oral Tablet | DRUG | Unit-dose placebo tablet delivered as two 3-mg placebo tablets |
Inclusion Criteria: 1. Understands the study information provided and is capable of giving written informed consent, in the opinion of the investigator or designee. 2. Has confirmed HIV-1 infection. 3. Has received ART that was initiated within 6 months of the estimated date of HIV-1 acquisition. T...