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Project Topic
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PrEPVacc is a Phase IIb, three-arm, two-stage HIV efficacy vaccine trial with a second randomisation to compare the newer PrEP drug Descovy to the established standard for PrEP, Truvada. The trial will take place at 5 clinical research centres located in 4 countries (Durban, South Africa; Maputo, Mozambique; Mbeya and Dar es Salaam, Tanzania; Masaka, Uganda) in Africa and aims to recruit 1668 participants (556 participants/arm) from high risk populations. This is a highly collaborative, multi-disciplinary project, co-ordinated by Imperial College with 13 beneficiaries from Africa, Europe, and the US, all of whom have extensive experience in HIV vaccine and/or prevention trials. PrEPVacc is an African study, with the trial database, trial management and co-ordination carried out at the MRC/UVRI (UNHRO)Uganda Research Unit, supported by MRC CTU at UCL. In the first reporting year, one of the main objectives of the project was to set up a feasibility study (registration cohort study) at all the clinical sites to identify, recruit, and follow-up a cohort of adult HIV-negative volunteers likely to have high rates of HIV infection to more accurately determine the incidence, and facilitate a timely enrolment of cohort participants eligible for the vaccine trial. During this year, the study protocol and study documents were developed by the PrEPvacc clinical teams for in country ethics submissions and all sites received national and local ethics approval to enroll participants into the registration cohort. By the end of 2018, 4 out of 5 centres had successfully screened and enroled participants into this study. Although the studies are independent, they utilize a common database established by MRC/UVRI (UNHRO)Uganda Research Unit. Preparations for the vaccine trial also began in the first reporting period, and the vaccine trial protocol was written and approved by the research ethics committee of the project sponsor. Capacity building has been well established during this reporting period. Two clinicans from Tanzania have registered for PhD programmes funded by the Swedish government and are evaluating HIV vaccines in high risk populations in Tanzania. Knowledge transfer and expertise from PrEPVacc partners has been provided to the clinical centres in order to facilitate the development of both current and future clinical and research capacity.
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