IAVI and Moderna launch first-in-Africa clinical trial of mRNA HIV vaccine development program
The nonprofit scientific research organization IAVI and Moderna, Inc, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant screenings are soon to start for a Phase I clinical trial of an mRNA HIV vaccine antigen (mRNA-1644) at the Center for Family Health Research (CFHR) in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa
The IAVI-sponsored trial, IAVI G003, builds on progress in HIV vaccine research. Recent findings from 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 (healthy U.S. adults). The immune response — targeting and expanding a specific class of B cells — is needed to start the process of developing broadly neutralizing antibodies (bnAbs). The induction of bnAbs is widely considered to be a goal of an efficacious HIV vaccine, and this B-cell activation is the first step in that process. IAVI G003 is designed to test the hypothesis that vaccination with eOD-GT8 60mer, developed by scientific teams at IAVI and Scripps Research, delivered via Moderna’s mRNA platform, can induce similar immune responses in African populations as was seen for IAVI G001.
The United States President’s Emergency Plan for AIDS Relief (PEPFAR), administered by the United States Agency for International Development, has made IAVI G003 possible (USAID). The Bill and Melinda Gates Foundation contributes to Moderna and the Collaboration for AIDS Vaccine Discovery (CAVD) Vaccine Immunology Statistical Center via funds (VISC)
For IAVI G003, 18 healthy, HIV-negative adult volunteers are expected to be enrolled across all trial locations. All participants will get two doses of eOD-GT8 60mer mRNA, which contains a fragment of the viral sequence but is not capable of causing HIV infection.
Trial endpoint analysis for IAVI G003 will be conducted using immunological assays and completed primarily by scientists at the KAVI-Institute for Clinical Research (KAVI-ICR) in Nairobi, Kenya; the Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast (KEMRI-CGMRC) in Kilifi, Kenya; and in part by scientists at the CAVD-Central Services Facility; IAVI’s Neutralizing Antibody Center (IAVI NAC) at Scripps Research, in La Jolla, California; and the VISC.
The CFHR, Aurum Institute, KAVI-ICR, and KEMRI-CGMRC are part of the Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) program and the IAVI-ADVANCE Partner Clinical Research Center (CRC) Network. ADVANCE is a 10-year cooperative agreement with PEPFAR through USAID that provides a platform to further development of an efficacious HIV/AIDS vaccine and strengthen vaccine research capacities in Africa. This initiative has enabled African research institutions and scientists to play key roles in the design and evaluation of novel biomedical prevention products using promising technologies.