Clinical Trials Logo
  1. Home
  2. HIV-1 Infection
  3. NCT05604209

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
See also
  Status Clinical Trial Phase
Recruiting NCT03940521 - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Completed NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Active, not recruiting NCT04022967 - ANRS 12372 MODERATO Study Phase 3
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Not yet recruiting NCT06337032 - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments Phase 4
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Withdrawn NCT05769569 - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission Phase 1
Enrolling by invitation NCT05584397 - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Not yet recruiting NCT04894357 - Impact of V106I on Resistance to Doravirine
Completed NCT04963712 - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Phase 1
Completed NCT04388904 - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Phase 4
Not yet recruiting NCT04311944 - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD N/A
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Not yet recruiting NCT04311957 - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults Phase 4
Completed NCT04568239 - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Completed NCT03998176 - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE Phase 4