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Moderna and IAVI Launch Clinical Trial of mRNA HIV Vaccine

The first doses of Moderna and IAVI’s mRNA HIV vaccine have been administered in the phase 1 IAVI G002 clinical trial.

Today, Moderna announced that they have administered the first doses of an experimental HIV vaccine with their partner, nonprofit scientific research organization IAVI. The clinical trial is testing the safety and efficacy of delivering HIV immunogens via messenger RNA (mRNA) 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," said Mark Feinberg, MD, PhD, president and CEO of IAVI.

Phase 1 of the trial, IAVI G002, looks to induce specific classes of B-cell responses and hasten their maturation into broadly neutralizing antibodies (bnAb). The immunogens tested in IAVI G002 were developed by IAVI and Scripps Research investigators and are administered with Moderna’s mRNA technology.

In addition to testing the desired immune response of the priming antigen (eOD-GT8 60mer) delivered with mRNA vaccination, IAVI G002 assesses the ability of a boosting immunogen to induce further maturation of B cells. Inducing bnAbs via B-cells is largely acknowledged as the goal of HIV vaccination.

The HIV antigens being evaluated for mRNA vaccination were originally developed as protein by William Schief, PhD, a professor at Scripps Research and the executive director of vaccine design at the IAVI Neutralizing Antibody Center.

Last year, Schief shared results from the IAVI G001 clinical trial that suggested an adjuvanted protein-based version of eOD-GT8 60mer induced the sought-after B-cell response in 97% of recipients. "We've seen promising proof of concept for germline targeting in IAVI G001, and this trial lets us take that approach to the next stage. What's more, we've been able to expedite production of clinical trial material at a remarkably rapid pace because of Moderna's technology," Schief said.

IAVI and Scripps research developed the eOD-GT8 60mer and Core-g28v2 60mer mRNA candidates with support from the Bill & Melinda Gates Foundation, the Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery at NIAID at the NIH, and Moderna.