The African led trial of preventing HIV has been launched in Masaka, central Uganda. 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 (one of several medications that are currently used to treat HIV and hepatitis B virus infection) taken daily.
PrEP is a proven intervention that has been shown to prevent HIV, where an antiretroviral 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, it is 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.
Nowhere has the devastation from HIV/AIDS been more greatly felt than in sub-Saharan Africa.
In Uganda, 1.4 million people are living with HIV.
While there have been increased efforts to scale up treatment initiatives in Uganda there are still many people living with HIV who do not have access to the medicines they need.
As of 2018, the estimated HIV prevalence among adults (aged 15 to 49) stood at 5.7%.2 Women are disproportionately affected, with 8.8% of adult women living with HIV compared to 4.3% of men.
Experts speak out
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,” said Weber.
“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 enroll 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.”
What is an HIV preventive Vaccine?
– A preventive vaccine teaches the body’s immune system to prevent a particular infection or fight a disease, to keep you healthy.
The world does not yet have a licensed vaccine to prevent HIV. In order to develop an HIV vaccine, researchers need to test it in people, to find out if it might help prevent or fight HIV. It is given as an injection.
What is oral PrEP?
– PrEP is the use of antiviral drugs by HIV-negative individuals to reduce their risk of HIV infection.
PrEP has been shown to prevent HIV and is available globally as a tablet taken through the mouth. Possible side effects- Like most available medications and vaccines that we take, we know that there can be reactions or side effects.
This may include fever, headaches, nausea, aches, pains and fatigue. In some people PrEP can cause minor side effects like nausea, bloating, diarrhea and headache. These side effects usually disappear over time.