With the participation of African experts, breakthroughs are underway in an mRNA vaccine against HIV.
The nonprofit scientific research organization, International AIDS Vaccine Initiative (IAVI) and Moderna announced that the first selections of participants for a Phase I clinical trial of an HIV mRNA vaccine will soon begin at the Center for Family Health Research (CFHR) in Kigali, Rwanda, and the Aurum Institute in Tembisa, South Africa.
The Phase I trial in Rwanda and South Africa aims to assess the safety and immunogenicity of the HIV mRNA vaccine antigen and build regional scientific capacity.
This new research means that the world is not only more than one step closer to an HIV vaccine, but is currently striving to ensure the safety and efficacy of existing mRNA vaccines through ‘clinical tests. Africa is at the center of this development.
World HIV Vaccine Awareness Day was celebrated on May 18. As the battle against this epidemic has been a tumultuous stage for decades, this day is remembered as a time to give thanks to healthcare workers, scientists, researchers, volunteers and community members.
The World Health Organization (WHO) reports that at the end of 2020, 37.7 million people were living with HIV worldwide. The burden of HIV continues to vary from country to country.
According to a report compiled by Statistics SA in 2021, the estimated HIV prevalence rate was 13.7%. The total number of people living with HIV was estimated at 8.2 million. While 19.5% of the population, aged 15 to 49, was HIV positive.
The IAVI G001 phase I clinical trial showed that vaccination with the HIV immunogen eOD-GT8 60mer as recombinant proteinsafely induced targeted immune responses in 97% of recipients who were not living with HIV.
The safe induction of the targeted response means that the vaccine was shown to be safe and produced up to 97% preventive immune response for a person who is not living with HIV.
The desired vaccine immune response can be achieved by targeting and expanding a specific class of B cells that are needed to start the process of developing large-scale neutralizing antibodies (bnAbs). The introduction of bnAbs is considered a goal of producing an effective HIV vaccine in the body, and the activation of B cells is the first step in this process.
“The road to an HIV vaccine has been long and winding. mRNA technology has the potential to accelerate the development of a safe, effective, affordable and sustainable HIV vaccine for use around the world,” said IAVI President and CEO, Mark Feinberg.
More than a clinical trial
Trial sites are expected to recruit 18 “healthy” IAVI G003 seronegative adult volunteers. All participants will receive two doses of eOD-GT8 60mer mRNA, which contains part of the viral sequence. These doses cannot cause HIV infection.
The scientists said it was important that all trials were unblinded and that there was no randomisation in the study. Enrolled participants will be monitored for safety for six months after receiving the last dose, and their immune responses will be examined closely and in detail to assess whether targeted responses will be achieved. The main test is for safety and immunogenicity, defined as the ability of a substance to activate an immune response.
This objective for IAVI G003 will be conducted using immunoassays and will be primarily completed by scientists.
The ADVANCE initiative has enabled African research institutions and scientists to play a key role in the design and evaluation of biomedical prevention products using new and promising technologies. Collaborators of this initiative will engage IAVI G003 study participants in parallel socio-behavioral research to understand the sampling techniques that were at play, such as fine needle aspiration, leukapheresis, and blood collection, which are used in the trial and the impact of trial participation on individuals.
“I think this is a game-changing approach to HIV vaccine design and development, and I hope we are on the right track to finally achieve an HIV vaccine,” said declared Etienne Karita, director of the CFHR.
“This is the first time we have evaluated an mRNA-delivered HIV immunogen in Africa with African scientists and researchers at the helm, building on our longstanding partnerships with USAID and IAVI. – e-Health News