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Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART

NCT05604209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-24

Study results available
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Summary

This is a double blind, randomized, placebo-controlled, parallel design study in which 18 in participants with HIV (PWH) on suppressive antiretroviral therapy will be randomly assigned to receive vaccination with C62 followed by M4 (C62-M4), C62 and C1 followed by M4 and M3 (C1C62-M3M4), or placebo.

The purpose of this study is to find out:

* If it is safe for people to receive intramuscular (IM) vaccination with C62-M4 or C1C62-M3M4
* If giving participants these vaccine doses will improve their immune system response to help the body get rid of HIV in the cells

Conditions

Interventions

BIOLOGICAL

ChAdOx1.HIVconsv62

Administered intramuscularly (IM) at Day 0

BIOLOGICAL

ChAdOx1.tHIVconsv1

Administered intramuscularly (IM) at Day 0

BIOLOGICAL

MVA.tHIVconsv4

Administered intramuscularly (IM) at Day 28

BIOLOGICAL

MVA.tHIVconsv3

Administered intramuscularly (IM) at Day 28

OTHER

Placebo

Administered at intramuscularly (IM) Day 0 and Day 28

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cynthia L Gay, MD, MPH · University of North Carolina

  • Nilu Goonetilleke, PhD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2024-09-12
Completion
2025-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604209 on ClinicalTrials.gov