With the participation of experts from Africa, inroads are being made into an mRNA HIV vaccine.
The non-profit scientific research organisation, International AIDS Vaccine Initiative (IAVI) and Moderna announced that the first participant screenings for a Phase I clinical trial of an mRNA HIV vaccine are going to start soon at the Centre 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 evaluate the mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity.
This new research means that the world is not only more than a step closer to an HIV vaccine, but is currently actively moving towards ensuring the safety and efficacy of the existing mRNA vaccines through clinical trials. Africa is at the centre of this development.
World HIV Vaccine Awareness Day was observed on 18 May. Since the battle against this epidemic has been a tumultuous stride over decades, this day is remembered as a time to thank healthcare workers, scientists, researchers, volunteers, and community members.
The World Health Organisation (WHO) reports that at the end of 2020, 37.7 million people were living with HIV around the world. The burden of HIV continues to vary between countries.
According to a report compiled by Statistics SA in 2021, the estimated prevalence rate of HIV was 13.7%. The total number of people living with HIV was estimated to be 8.2 million. While 19.5% of the population, aged 15-49 years, was HIV positive.
The Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein, safely induced the targeted immune responses in 97% of recipients who were not living with HIV.
The safe induction of the targeted response means that the vaccine proved to be safe and produced a preventative immune response up to 97% for an individual who is not living with HIV.
The desired immune response from the vaccine can be achieved by targeting and expanding a specific class of B cells that are needed to start the process of developing broadly neutralising antibodies (bnAbs). The introduction of bnAbs is considered a goal to produce an HIV vaccine that is effective in the body, and the B-cell activation is the first step in that 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 durable HIV vaccine for use throughout the world,” said president and CEO of IAVI, Mark Feinberg.
More than a clinical trial
The trial sites are expected to enroll 18 “healthy” and HIV-negative adult volunteers for IAVI G003. All the participants will receive two doses of eOD-GT8 60mer mRNA, which contains a portion of the viral sequence. These doses cannot cause an HIV infection.
Scientists said that it was important for all trials not to be blinding and for there to be no randomisation in the study. Enrolled participants will be monitored for safety for six months after they receive the last dose, and their immune responses will be examined closely and in detail to evaluate whether the targeted responses will be achieved. The primary trial aims for safety and immunogenicity which is defined as the ability of a substance to activate an immune response.
This aim for IAVI G003 will be conducted using immunological assays and will primarily be completed by scientists.
The ADVANCE initiative has enabled African research institutions and scientists to play key roles in the design and evaluation of biomedical prevention products using new and promising technologies. The collaborators from this initiative will engage IAVI G003 study participants in parallel socio-behavioural research to understand the sampling techniques that were in play, such as the fine needle aspiration, leukapheresis, and blood drawing procedures, which are used in the trial and the impact of trial participation on individuals.
“I think this is a revolutionary approach to HIV vaccine design and development, and I am hopeful that we are on the path to finally realising an HIV vaccine,” said Etienne Karita, Director of CFHR.
“This is the first time we are evaluating an mRNA-delivered HIV immunogen in Africa with African scientists and researchers at the helm, building on our longstanding partnerships with USAID and IAVI.” – Health-e News