drugset / Trial / NCT05208125
A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals
Phase 1
Completed
30 enrolled
IrsiCaixa
Beatriz Mothe Pujadas PhD,MD · collabJosé Moltó Marhuenda, PhD, MD · collabLucía Bailón Álvarez, MD · collabSusana Benet Garrabé, PhD,MD · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7 gp140 adjuvanted with MPLA liposomes in 30 virologically-suppressed ART-treated HIV-1 positive individuals.
Timeline
- Start
- 2022-03-30
- Primary completion
- 2022-03-30
- Completion
- 2023-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAdOx1.HTI | Vaccine | 5e+10 vg | Intramuscular |
| Subject | ConM SOSIP.v7 | Vaccine | 100 ug | Intramuscular |
| Subject | MVA.HTI | Vaccine | 2e+08 unknown | Intramuscular |
| Background | MPLA | Unknown | 500 ug | Intramuscular |