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

Name: Clinical Trial NCT05208125
Creator: IrsiCaixa
Keywords: HIV Infection, ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS)., Phase 1, biological, clinical trial, Spain

IrsiCaixa·Phase 1·ClinicalTrials.gov·biologicalActive, not recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: HIV Infection
Drug/Device/Intervention: ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: IrsiCaixa
Location: Badalona, Spain

Timeline & enrollment

Phase: Phase 1
Start date: Mar 30, 2022
End date: Dec 18, 2023
Enrollment: 30 participants

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

HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05208125
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.