A new trial called PrEPVacc is testing two vaccines with two forms of pre-exposure prophylaxis (PrEP) to test vaccine efficacy and provide protection against HIV transmission. The trial sites for the PrEPVacc study include; Durban, South Africa, Masaka, Uganda, Dar es Salam, and Mbeya....CONTINUE READING
According to UNAIDS, about 630,000 people died from AIDS-related illness globallyin 2022, while 39 million people were living with HIV. About 1.3 million people were also newly infected last year.
After 36 years since the first HIV vaccine trial, with the support of International communities, the trial is underway in Entebbe, Uganda, and scientists hope the PrEPVacc willsucceed where other trials fell short as the medical community is yet to have a working vaccine.
The clinical trial, which took place in Thailand in 2009, had shown modest effectiveness
in preventing HIV infection with the efficacy of the vaccine, RV144
, being 30%. However, for PrEPVacc to be considered a success, either of the two vaccines being tested needs to achieve an efficacy of at least 70%.
One of the vaccines combines pieces of synthetic HIVDNA with a protein base, while the other combines DNA, MVA (a weakened pox virus), and a protein base, similar to that used in RV144.
The clinical trial which beganenrollment in December 2020, signed up 1,513 participants finally in March 2023. The participants are aged between 18-40 years old and live in South Africa, Uganda, or Tanzania.
Although, the three countries are among the top 15 countries in the world with high rates of HIV/AIDS in adults
, Eugene Ruzagira, PrEPVacc, the trial director, said it was necessarily not why they were chosen to participate. Rather, the countries had experience doing HIV prevention studies, as well as in vaccine trials, and have established very good connections with the communities, while possessing the infrastructure required for the trial.
Though funding for PrEPVacc came from the European Union-sponsored EDCTP
, Jonathan Weber, the lead applicant and coordinator of PrEPVacc, and director of the Imperial College Academic Health Science Centre in London said the trial genuinely needed to be an African study led by Africans and coordinated in Africa, where the data is analyzed in Africa and the laboratory work is done in Africa.
In the trial, every participant receives four injections of either vaccine A or B or a saline placebo, following a 48-week schedule. They will also receive a course of daily PrEP until week 26, which is a fortnight after the third injection. The reason behind this timing, as explained by Ruzagira, is that the immune response is expected to reach its peak around that period.
The US Centers for Disease Control and Prevention
estimates that PrEP taken as prescribed will reduce the risk of getting HIV from sex by about 99% and at least 74% among people injecting drugs by.
The PrEPVacc trial is providing two types of PrEP pills, Truvada or Descovy, and checking whether the newer Descovy is as effective as or better than Truvada (Note: Descovy is currently FDA-approved for men but not women). This marks the first time combining a trial HIV vaccine with PrEP.
