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

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.

Timeline

Start

2020-12-15

Primary completion

2024-12-31

Completion

2024-12-31

Publications

• Iseselo MK, Tarimo EAM, Ambikile JS, Lukumay GG, Munseri P, Bakari M, Lyamuya E, Aboud S; PrEPVacc Trial Team. Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania. Trials. 2026 Jul 6. doi: 10.1186/s13063-026-09835-9. Online ahead of print.
• Kawuma R, Nakamanya S, Tarimo E, Chimukuche RS, Ambindwile J, Pamba D, Kusemererwa S, Munseri P, Singh N, Dube K, McCormack S, Ruzagira E, Seeley J; PrEPVacc trial team. Understanding trial designs and acceptability of participation in an HIV vaccine trial with concurrent randomisation to oral pre-exposure prophylaxis in East and Southern Africa: a longitudinal qualitative study. Trials. 2026 May 16;27(1):412. doi: 10.1186/s13063-026-09774-5.
• McCormack S, Dunn D, Kusemererwa S, Munseri P, Singh N, William W, Mutonyi G, Bern H, Goldwirt L, Kingsley C, Kroidl A, Hansen CH, Ding S, Kawuma R, Amondi M, Bahemuka U, Buma D, Clutterbuck D, Gaffoor Z, Jennings A, Joachim A, Kakande A, Kalanzi B, Kisinda A, Matsoso M, Miller T, Morar N, Musau J, Nabbuto J, Nzuza A, Pamba D, Salomone S, Sithole T, Tarimo E, Woeber K, Chinyenze K, Gray G, Lyamuya E, Bakari M, Aboud S, Maganga L, Doncel G, Seeley J, Weber J, Kaleebu P, Fox J, Ruzagira E; PrEPVacc Study Group. A Comparison of F/TAF and F/TDF as HIV Pre-Exposure Prophylaxis in a Predominantly Cisgender Women Population in East and South Africa: A Randomized, Factorial, Noninferiority Trial. J Acquir Immune Defic Syndr. 2026 Jun 1;101(6):655-662. doi: 10.1097/QAI.0000000000003845.
• Ambikile JS, Tarimo EAM, Iseselo MK, Lukumay G, Munseri P, Bakari M, Lyamuya E, Aboud S, Kawuma R, Seeley J. The experience of trial participation disclosure among sex workers in a phase IIb HIV vaccine trial: A qualitative study in urban Tanzania. PLOS Glob Public Health. 2025 Nov 19;5(11):e0005511. doi: 10.1371/journal.pgph.0005511. eCollection 2025.
• Chimukuche RS, Shandu L, Zulu S, Khanyile P, Singh N, Gaffoor Z, Kawuma R, McCormack S, Seeley J; PrEPVacc Study Group. HIV risk perception, trust and PrEP adherence among participants in an HIV prevention trial: a qualitative longitudinal study, South Africa. BMJ Open. 2025 Apr 23;15(4):e086742. doi: 10.1136/bmjopen-2024-086742.
• Chimukuche RS, Kawuma R, Mahapa N, Mkhwanazi S, Singh N, Siva S, Ruzagira E, Seeley J; PrEPVacc Study Group. Examining oral pre-exposure prophylaxis (PrEP) literacy among participants in an HIV vaccine trial preparedness cohort study. BMC Health Serv Res. 2022 Nov 10;22(1):1336. doi: 10.1186/s12913-022-08730-8.

Drugs

Indications