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Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults

NCT03844386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-08-09

Study results available
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Summary

This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4), M3+M4 combined, or placebo. Participants will be randomized 7:7:7:3 to one of four study arms, and receive study treatment or placebo at Day 0. Each enrolled participant will complete the study in approximately 33.5 weeks (8.4 months).

The purpose of this study is to find out:

* If it is safe for people to receive injections of two investigational HIV vaccines, called MVAtHIVconsv3 and MVAtHIVconsv4 alone or in combination.
* If giving participants these vaccine doses will increase their immune system's ability to kill HIV virus.

Conditions

  • HIV-1 Infection

Interventions

BIOLOGICAL

MVA.tHIVconsv3

viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1

BIOLOGICAL

MVA.tHIVconsv4

viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1

OTHER

Placebo

The appropriate amount of Sodium Chloride for Injection USP, 0.9% will be drawn into a syringe.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cindy L Gay, MD, MPH · UNC-Chapel Hill

  • Nilu Goonetilleke, PhD · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2021-11-11
Completion
2022-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03844386 on ClinicalTrials.gov