CIDRI clinical research site in Khayelitsha joins the HVTN702 trial

The Clinical Infectious Diseases Research Initiative (CIDRI) clinical research site located at Site B Community Health Centre in Khayelitsha has been activated as one of the trial sites to participate in the pivotal HVTN702 randomised controlled trial assessing the safety and efficacy of the novel HIV vaccine (ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59). It is one of fifteen sites across South Africa participating in this trial. The other site in Cape Town is Emavundleni in Crossroads run by UCT's Desmond Tutu HIV Centre. The Emavundleni site has been recruiting since late 2016.

The trial aims to enroll 5,400 men and women aged 18-35 years. It is planned that each of the 15 sites will enroll 360 HIV-negative participants over a 2-year period. Each participant will be followed for 2-3 years in the study.

The vaccine used in HVTN 702 is based on the vaccine investigated in the RV144 clinical trial in Thailand. The Thai trial delivered landmark results in 2009: the experimental vaccine regimen it tested was found to be 31 percent effective in preventing HIV infection over the 3.5-year follow-up period after vaccination.

In the HVTN 702 study, the vaccination schedule and vaccine components of the RV144 vaccine regimen have been modified in an attempt to increase the magnitude and duration of the protective immune responses elicited. Funders of the trial are the National Institute for Allergy and Infectious Diseases (NIAID), the Bill & Melinda Gates Foundation, and the South African Medical Research Council (MRC).

The principal investigator at the Khayelitsha site is Professor Graeme Meintjes. The trial staff of over 20 members has worked hard over the past 6 months to prepare the site for the trial in terms of training and developing clinical, regulatory laboratory and pharmacy infrastructure and capacity. A Community Advisory Group (CAG) of 12 community members has also been established and has advised the trial team on strategies for messaging and recruitment in the community. Meintjes said: "This is the first time that the community of Khayelitsha has the opportunity to participate in an HIV vaccine trial. This is fitting given the key role that members of this community have played in the fight against the HIV epidemic through activism and disseminating knowledge about the virus to combat its spread. The ongoing burden of new HIV infections among young people in this and many other communities in South Africa means that its vital to develop and evaluate new prevention methods."

The Khayelitsha HVTN702 trial team at Site B Community Health Centre