A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.
Do the preventative vaccines used in this study help stop people catching HIV ? Is Descovy PrEP as good as Truvada PrEP at preventing HIV in heterosexuals?
What is this study about?
The study is about preventative (prophylactic) vaccines for HIV and will assess their effectiveness compared to a placebo in preventing people becoming HIV positive.
The study will also assess the effectiveness of Descovy PrEP, compared to the effectiveness of Truvada PrEP and a hypothetical placebo. The safety of each vaccine combination regimen compared to placebo and compared to Descovy and Truvada PrEP will also be assessed.
Type of study
Who is funding the study?
The PrEPVacc project is mainly funded by the second European and Developing Countries Clinical Trials Partnership (EDCTP2), a collaboration between countries in Europe and sub-Saharan Africa supported by the European Union, to improve the health of Africans by doing important research trials [TRIA2015- 1078].
When is it taking place?
The trial opened in 2020 and recruitment finished in March 2023. The trial will run through most of 2024. A total of 1,514 participants were recruited into the study.
Where is it taking place?
Clinical research centres in South Africa, Tanzania and Uganda.
Who is included?
HIV negative adults aged 18-40 years old.