Moderna has announced that they not only developed an mRNA vaccine for HIV but that the first participants in phase 1 of their study have been dosed. This is big news for not only the adult industry but the entire world.

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. In 2021, Dr. 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.

The Schief lab has been a pioneer of the vaccine design approach known as germline targeting. Naive B cells display antibodies encoded by unmutated, or “germline” genes. A series of vaccines, which would begin with the prime-boost immunogens tested here, may be able to target specific naive B cells and induce them to mature into bnAb-producing ones. In the lab, bnAbs have been shown to neutralize a broad range of HIV variants, and one bnAb, VRC01, was recently shown to be capable of protecting humans against infection by neutralization-susceptible HIV strains. VRC01 is a member of the class of bnAbs targeted in IAVI G001.

“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,” said Schief.

We will keep you updated as more information about Moderna’s mRNA HIV vaccine becomes available.

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