NEW YORK – The nonprofit scientific research organization IAVI and Moderna, Inc. (Nasdaq:MRNA), 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.
IAVI G003 is made possible by the support of the American people through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID). Additional support is provided by the Bill & Melinda Gates Foundation through grants to Moderna and to the Collaboration for AIDS Vaccine Discovery (CAVD) Vaccine Immunology Statistical Center (VISC).
“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 Mark Feinberg, M.D., Ph.D., president and CEO of IAVI. “IAVI G003 harnesses Moderna’s proven mRNA vaccine technology, a novel HIV vaccine approach developed over many years by IAVI and Scripps Research, and more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by USAID. Together, we aim to answer critical research questions that can advance HIV vaccine development that increasingly involves leadership by scientists in countries where a vaccine is needed most.”
“With our mRNA technology and IAVI’s discovery and development expertise, we are looking forward to advancing a novel approach to overcome some of the longstanding hurdles to developing a protective HIV vaccine. Moreover, we are grateful for the opportunity to work in partnership with researchers and scientists from communities heavily burdened by HIV,” said Stéphane Bancel, CEO of Moderna. “Moderna’s HIV vaccine development program, together with our portfolio of COVID-19, Zika, and Nipah programs, advances 4 of the 15 priority vaccine programs we committed to develop by 2025, targeting infectious diseases that threaten global health.”
Trial sites are expected to enroll a combined total of 18 healthy, HIV-negative adult volunteers for IAVI G003. All participants will receive two doses of eOD-GT8 60mer mRNA, which contains a portion of the viral sequence and cannot cause an infection with HIV. There is no blinding and no randomization in this open-label study; all participants will receive the intervention. Enrolled participants will be monitored for safety for six months after receipt of the last dose, and their immune responses will be examined in molecular detail to evaluate whether the targeted responses will be achieved. The primary trial endpoints are safety and immunogenicity, defined as the ability of a substance to elicit an immune response.
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.