IAVI and Moderna announced that first doses have been administered in a clinical trial of experimental HIV vaccine antigens, according to a news release from IAVI, a nonprofit research organization.
The Phase I 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.
The sites participating in the trial are George Washington University (GWU) School of Medicine and Health Sciences, Hope Clinic of Emory Vaccine Center, Fred Hutchinson Cancer Research Center, and the University of Texas-Health Science Center at San Antonio.
The sites will enroll 56 healthy, HIV-negative adult volunteers. Forty-eight participants will receive one or two doses of eOD-GT8 60mer mRNA Vaccine (mRNA-1644), with 32 of them receiving the boost Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core). An additional eight volunteers will receive the boost immunogen alone. Participants will be monitored for safety for six months after last vaccination.
“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, MD, PhD, President and CEO of IAVI.
The Bill & Melinda Gates Foundation is funding the trial.
The HIV vaccine antigens being evaluated as mRNA in this study were originally developed as proteins by William Schief, PhD, Professor at Scripps Research and Executive Director of Vaccine Design at IAVI’s Neutralizing Antibody Center (NAC), and colleagues.
In 2021, Schief announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen (eOD-GT8 60mer) induced the desired B-cell response in 97% of recipients. IAVI G002 not only tests priming of the desired immune response using mRNA delivery of eOD-GT8 60mer, but also assesses the ability of a boosting immunogen to induce further maturation of B cells. 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.