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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: IrsiCaixa · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will be randomized to receive either the combined regimen with T- and B-cell immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1. Safety and immunogenicity of the combined T- and B-cell regimen will be measured up to week 30 (2 weeks after last ConM SOSIP.v7/placebo administration). At week 30, all participants will undergo an ATI of 24 weeks of duration. At visit week 54 (End-of-ATI visit), or before according to pre-specified criteria, ART will be resumed. Efficacy endpoints will be measured at 12 and 24 weeks of ATI (study visits week 42 and 54). After ART resumption, participants will be followed during an additional safety period of 12 weeks (study visit week 66, End-of-Study visit). Treatment allocation will remain blinded until week 54 (End-of-ATI visit).

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).	Intramuscular administration of 1 x ChAdOx1.HTI (5x1010 Vp), 3 x ConM SOSIP.v7 (100μg) adjuvanted with MPLA liposomes (500μg), and 1 x MVA.HTI (2x108pfu)
OTHER	Normal saline solution	Intramuscular administration of normal saline solution

Timeline

• Start date: 2022-03-30
• Primary completion: 2022-03-30
• Completion: 2023-12-18
• First posted: 2022-01-26
• Last updated: 2024-05-07

Locations

1 site across 1 country: Spain