The first volunteer in the PrEPVacc trial receiving their first set of injections and medicines. The trial will be conducted among healthy male and female volunteers aged 18-40 years and likely to be at risk of HIV.
The PrEPVacc trial, testing two ways to prevent HIV at the same time has begun giving its first injections and medicines to participants, at the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine (MRC/UVRI and LSHTM) Uganda Research Unit. The first HIV vaccine efficacy trial to be funded outside the US, PrEPVacc is African-led and European-supported.
PrEPVacc is, for the first time, trialing two HIV vaccine regimens, and at the same time testing a new form of daily oral pre-exposure prophylaxis (PrEP) against the existing standard for PrEP. One vaccine regimen combines DNA with protein based vaccine, and the other combines DNA, MVA and protein based vaccine. Some participants will receive a placebo that does not contain vaccine, which will be a sterile liquid called saline. Both these regimens have already been tested in clinical trials and have demonstrated their safety.
PrEPVacc will also test whether a new form of oral PrEP, Descovy, taken daily, is equivalent or more effective than Truvada taken daily. PrEP is a proven intervention that has been shown to prevent HIV, where an anti-retroviral drug is taken prior to being exposed to HIV. Participants will be offered PrEP during the vaccine immunization phase (6 months).
Prof. Pontiano Kaleebu, the Director of MRC/UVRI and LSHTM Uganda Research Unit and the PrEPVacc Chief Investigator said, “PrEPVacc provides two great opportunities; first, for Africans to be able to participate and lead in the first HIV prevention trial to test two ways to prevent HIV, a scourge that has ravaged the continent and secondly, an opportunity to grow the capacity of African sites to do future trials themselves and to foster our own future leaders,” he added.
The trial will be conducted among healthy male and female volunteers aged 18-40 years and likely to be at risk of HIV. As part of the trial, participants will attend scheduled clinic visits to the research sites and undergo HIV testing and provide blood, urine and other samples at the required time points. Participants can freely withdraw from the research at any time.
Professor Jonathan Weber, Dean of the Faculty of Medicine at Imperial College London, UK, which is sponsoring the PrEPVacc trial, said: “The first PrEPVacc trial participants in Masaka are helping their communities, and the world, by answering important questions about how we can best prevent HIV in future. These volunteers are critical to the success of PrEPVacc, but we would not be in a position to ask these questions without the efforts of many other participants and researchers in the past. PrEPVacc builds on a long history of partnerships between African countries and European institutions, including EuroVacc, AfrEVacc, TaMoVac and MDP. I have been working at Imperial College London on ways to prevent HIV since the virus was first discovered and I am immensely proud that we now have this African-led, European-supported trial beginning in Uganda.”
Besides the MRC/UVRI and LSHTM Uganda Research Unit site in Masaka, which is coordinating all study site activities, the PrEPVacc trial is planned to be conducted at four other sites in three countries: Mbeya, Tanzania; Dar-es-Salaam, Tanzania; Maputo, Mozambique and Durban, South Africa. This will be the first HIV efficacy trial ever to be conducted in East African countries. The trial aims to enrol a minimum of 1,668 participants across all its sites.
Findings from PrEPVacc will inform scientists as to whether developing either of the two different combination vaccine regimens for preventing HIV is worthwhile or not; and also whether a new form of PrEP is as acceptable, safe and effective as the available oral standard PrEP, in women as well as men.
Professor Sheena McCormack, PrEPVacc Project Lead, based at the Medical Research Council Clinical Trials Unit at University College London, UK, said: “PrEPVacc is a highly efficient and innovative study. While we are testing two different ways to prevent HIV at the same time, we are also using a novel trial design that means that, as the trial progresses, we can potentially spot where to save time and resources and focus on testing the vaccine regimens with the highest chance of success.”
“PrEPVacc is also addressing an important question about PrEP and its results will be valuable for informing future implementation and uptake strategies by local stakeholders and champions across East and Southern Africa where PrEP uptake is currently low.”
PrEPVacc is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), as part of the EDCTP2 Programme supported by the European Union.