SAMRC PrEPVacc HIV Prevention Vaccine clinical trial in full swing
Cape Town | While South Africa and the rest of the world continue to make encouraging progress in their response to the COVID-19 pandemic, the development of a safe and effective HIV prevention vaccine also remains critical for global health – something the South African Medical Research Council has not lost sight of.
Through its HIV Prevention Research Unit (HPRU), the SAMRC in October this year enrolled the first participant for the groundbreaking PrEPVacc Trial at its Verulam Clinical Research Site in Durban, KwaZulu-Natal. This historic enrollment brought the number of sites enrolling into the PrEPVacc study to four – including sites in Masaka, Uganda; Mbeya and Dar es Salaam in Tanzania.
PrEPVacc, a double blinded randomized placebo controlled clinical trial, is an African-led, European-supported HIV prevention study conducted in east and southern Africa from 2018 to 2023 – for the first time, it is combining the evaluation of experimental HIV vaccines and oral pre-exposure prophylaxis (PrEP) simultaneously. In this Phase 2b HIV prevention trial, all participants are offered oral PrEP in the initial phase of the study together with HIV Vaccine or placebo. This provision of PrEP is to compare efficacy of vaccines with effectiveness of use of oral Truvada against Descovy as pre-exposure prophylaxis – the outcomes will tell us whether the combined regimens can protect against HIV infection.
According to Mrs. Neetha Morar, senior research manager at HPRU, although the recent HIV vaccine trials results were not promising, they are pleased to state that the PrEPVacc trial in Durban and Africa is progressing well as we have built a trusting relationship with participants and community and garnered partnerships and support. “Our community at Verulam remain engaged with researchers and participants continue to come for screening and enrollment as part of their contribution to finding a HIV vaccine that may lead to future effectiveness trials,” said Mrs. Morar adding that this trust, mutual understanding, and partnership from the community have also contributed to the successful conduct of COVID-19 vaccine trials at the site.
Speaking to Morar, the fourth enrolled participant who is a 29-year-old mother of two (9-year-old daughter and 6-year-old son) from Ntuzuma, had this to say: “pills and vaccine in PrEPVacc are safe thus I participate as I want my kids to be living in a HIV free country and help find a vaccine. Let us be safer and use condoms for now”.
Dr Nishanta Singh, study site Principal Investigator (PI) said: “The team is proud to be a part of this groundbreaking and very relevant study. A safe and effective HIV Vaccine has eluded us for far too long and we are committed to moving closer to our goal of an HIV Free Future.”
SAMRC President and CEO, Prof Glenda Gray has commended the team for preparing for this HIV prevention study that is testing two ways to prevent HIV at the same time, saying that for more than five decades, the organisation has been at the forefront of cutting-edge research and innovation to tackle the HIV epidemic. “SAMRC scientists and those with close association with the organisation, have ranked among the world’s best in all aspects of the HIV response – from prevention of HIV infection from mother-to-child, to the development of newer and safer drug regimens, and the health service delivery of antiretroviral treatment,” said Prof Gray.
“As we mark the 33rd World AIDS Day under the theme: “End inequalities. End AIDS and End Pandemics”, with a special focus on reaching people left behind, we commemorate the collective lives lost globally while reflecting on the major strides we have made and our contribution and impact in HIV research.”
NOTE TO THE EDITOR
PrEPVacc aims to enroll 1,668 participants across four sites in Africa collectively by June 2022 with follow up expected to continue until 2023. PrEPVacc is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), as part of the EDCTP2 Programme supported by the European Union.
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