The trials of an mRNA vaccine for HIV in Rwanda, underway since 2021, have shown promising progress in their preliminary phases, according to officials in charge.
Sponsored by the International AIDS Vaccine Initiative (IAVI), a global not-for-profit organization, the trials are being conducted in two African countries—Rwanda and South Africa.
The trials aim to assess the effectiveness of eOD-GT8 60mer, an HIV immunogen developed by scientific teams at IAVI and Scripps Research, delivered via Moderna’s mRNA platform.
Known as IAVI G003, the trial in Rwanda and South Africa builds upon earlier advancements in HIV vaccine research, including findings from IAVI G001, a previous trial conducted in the USA. IAVI G001 demonstrated that vaccination with the immunogen safely induced the desired immune responses in 97 percent of healthy adult recipients in the US.
IAVI G003 seeks to test the hypothesis that vaccination with eOD-GT8 60mer can elicit similar immune responses in African populations as observed in IAVI G001.
Karie Youngdahl, Executive Director of Communications at IAVI shared insights on the progress made during the first phase of the trials and expressed optimism about their trajectory.
“All vaccinations have been administered in this trial, and volunteer follow-up and data analysis are ongoing. Given the complex nature of the vaccination approach pursued by IAVI and partners, we anticipate conducting more Phase I trials as we refine aspects of what we believe will be a sequential vaccine regimen,” she said.
“We are confident that the IAVI G003 Phase I trial is on a promising track. Earlier this year, we presented an interim analysis from a related US-based trial called IAVI G002 at scientific meetings and a Moderna forum. The preliminary results from mRNA delivery of the same vaccine candidate used in IAVI G003 suggest that the vaccine candidate, when delivered via mRNA, induces immunological responses that are equally or more robust than when delivered via protein in a previous US trial known as IAVI G001,” she added.
The IAVI G003 trial aims to enroll a total of 18 healthy, HIV-negative adult volunteers across multiple trial sites.
Each participant receives two doses of eOD-GT8 60mer, which contains a portion of the viral sequence and cannot cause HIV infection.
Participants are monitored for safety for six months after receiving the final dose, and their immune responses are extensively analyzed to evaluate the achievement of targeted responses.
The primary trial endpoints include safety and immunogenicity, which refers to the ability of a substance to elicit an immune response.
Dr. Gallican Rwibasira, the manager of the HIV Division at Rwanda Biomedical Center (RBC), emphasized the significance of such vaccine trials as an opportunity for Rwanda, a country guided by scientific evidence.
“Clinical trials provide the best evidence for strategies and interventions,” he said, adding that Rwanda’s well-established HIV program can attract further trials and clinical investigations to support continued control of the epidemic.
Dr. Rwibasira mentioned that the IAVI G003 trials are currently in the first phase, targeting individuals at low risk of HIV transmission. Subsequent phases will include populations at higher risk.
He further stated that the RBC and regulatory authorities like the Rwanda FDA are overseeing and monitoring the progress of the trials.