IAVI, the nonprofit scientific research organization and Moderna announced that first doses have been administered in a clinical trial of experimental HIV vaccine antigens at George Washington University (GWU) School of Medicine and Health Sciences in Washington, D.C.

The Phase 1 trial, IAVI G002 is designed to test the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development. The induction of bnAbs is widely considered to be a goal of HIV vaccination, and this is the first step in that process. The immunogens being tested in IAVI G002 were developed by scientific teams at IAVI and Scripps Research and will be delivered via Moderna's mRNA technology.

"We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna's mRNA platform. The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine," says Mark Feinberg, M.D., Ph.D., president and CEO of IAVI. "We are grateful to all of our partners and especially to the Bill & Melinda Gates Foundation for funding this trial."

"We are very pleased to be partnering with IAVI and the Bill & Melinda Gates Foundation to apply our mRNA technology in the setting of HIV. At Moderna, we believe that mRNA offers a unique opportunity to address critical unmet public health needs around the world," said Stephen Hoge, M.D., President of Moderna. "We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health."

The HIV vaccine antigens being evaluated as mRNA in this study were originally developed as proteins by William Schief, Ph.D., professor at Scripps Research and executive director of vaccine design at IAVI's Neutralizing Antibody Center (NAC), and colleagues. Given the speed with which mRNA vaccines can be produced, this platform offers a more nimble and responsive approach to vaccine design and testing, potentially shaving off years from typical vaccine development timelines.