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

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.

Timeline

Start

2019-04-22

Primary completion

2021-11-11

Completion

2022-04-04

Publications

• Gay CL, Xu Y, Weideman AMK, Shaw FR, Kuruc JD, Conrad SZ, Mariano SA, Samir S, Kallon S, Sponaugle AT, Warren JA, Clutton GT, Abad-Fernandez M, Kapper C, Bradley AB, Baker CE, Pedersen SM, Moeser MJ, Burke L, Wee EG, Crook A, Laird GM, Cyktor JC, Mellors JW, Zhou S, Fox L, Eron JJ, Margolis DM, Hudgens MG, Hanke T, Goonetilleke N. MVA.HIVconsvX vaccination-evoked T cell expansion inversely associates with age in people with HIV-1 on antiretroviral therapy. J Clin Invest. 2026 May 5;136(12):e193547. doi: 10.1172/JCI193547. eCollection 2026 Jun 15.

Drugs

Indications