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Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3m4 in Persons With HIV-1 Suppressed on ART — CM HIV-Core008  

HIV-1-infection Clinical Trial

Official title:
IGHID 12107 - A Phase I Study to Evaluate the Safety and Immunogenicity of the ChAdOx1.HIVconsv62 - MVA.tHIVconsv4 (C62-M4) or, ChAdOx1.tHIVconsv1+C62 - MVA.tHIVconsv3+M4 (C1C62-M3m4) PRIME-BOOST REGIMENS in Persons With HIV-1 Suppressed on Antiretroviral Therapy - The CM (HIV-Core 008) Study

Clinical Trial Summary

The purpose of this study is to evaluate whether intramuscular (IM) vaccination with C62-M4 or C1C62-M3M4 in persons with HIV-1 (PWH) on suppressive antiretroviral therapy (ART) will be safe and increase HIV-1-specific T cell responses targeting conserved regions of HIV-1.

Clinical Trial Description

This is a research study to find out if vaccination with either two or four investigational vaccines given at 2 separate visits will be safe, and to evaluate if the vaccines improve immune system response to help the body get rid of HIV in the cells. Study participants will be randomly assigned to receive one of the vaccines, or a placebo injection with no vaccine. Vaccines will be given as an intramuscular (IM) injection on Day 0 and 28 days later. After each injection, participants will be evaluated and monitored at the research clinic for any reactions. There are 11 non-vaccination study visits requiring blood tests and exams and 6 phone visits. In addition a leukapheresis (a blood collection procedure) will occur at 2 timepoints in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05604209
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Susan Pedersen, RN
Phone 919-966-6713
Email susan_pedersen@med.unc.edu
Status Recruiting
Phase Phase 1
Start date October 13, 2022
Completion date October 2024
View Details
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