IAVI and Moderna Launch First-in-Africa Clinical Trial of mRNA HIV Vaccine Development Program
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacityNEW YORK, NY and CAMBRIDGE, MA / ACCESSWIRE / May 18, 2022 / The nonprofit scientific …
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity
NEW YORK, NY and CAMBRIDGE, MA / ACCESSWIRE / May 18, 2022 / 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.
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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."