Overview

A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP

Status:
Not yet recruiting

Trial end date:
2023-03-01

Target enrollment:

Participant gender:

Summary

This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis. The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment. The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis. The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

Phase:

Phase 2

Details

Lead Sponsor:

MRC/UVRI and LSHTM Uganda Research Unit
MRC/UVRI Uganda Research Unit on Aids

Collaborators:

Centre Hospitalier Universitaire Vaudois
CONRAD
EuroVacc Foundation
Gilead Sciences
Imperial College London
Instituto Nacional de Saúde, Mozambique
International AIDS Vaccine Initiative
Karolinska Institutet
King's College London
Ludwig-Maximilians - University of Munich
Medical Research Council, South Africa
Muhimbili University of Health and Allied Sciences
National Institute for Medical Research, Tanzania
University College, London

Treatments:

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Vaccines