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 - Trial NCT05208125
Access comprehensive clinical trial information for NCT05208125 through Pure Global AI's free database. This Phase 1 trial is sponsored by IrsiCaixa and is currently Active, not recruiting. The study focuses on HIV Infection. Target enrollment is 30 participants.
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Study Focus
ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).
Interventional
biological
Sponsor & Location
IrsiCaixa
Timeline & Enrollment
Phase 1
Mar 30, 2022
Dec 18, 2023
Primary Outcome
Local IMP-related AEs of Grade 3 and 4,Systemic IMP-related AEs of Grade 3 and 4,Descriptive of AEs
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05208125
Non-Device Trial