First Patient Dosed in Trial of Trimer mRNA HIV Vaccine

Moderna has initiated its second phase 1 HIV vaccine trial based on germline targeting and immune-focusing approaches.

The most recent phase 1 trial dosed its first patient as part of an open-label, multicenter, randomized study (HVTN 302) that seeks to enroll approximately 100 HIV-negative adults, aged 18 to 55 years. The trial will evaluate the safety and immunogenicity of Moderna’s experimental HIV trimer mRNA vaccine (mRNA-1574).

Moderna has been using its mRNA vaccine technology platform for COVID-19 as well as other diseases.

"Developing a vaccine regimen that induces sustained protective levels of HIV neutralizing antibodies in humans has been difficult to achieve. At Moderna, we believe that mRNA offers an opportunity to take a fresh approach to this challenge," said Stephen Hoge, MD, president of Moderna, in a press release. "With the launch of our second HIV vaccine trial, we are advancing our strategy to utilize multiple mRNA encoded native-like HIV trimers and leverage the power of our mRNA platform to accelerate the discovery of a protective HIV vaccine."

Moderna is currently evaluating 2 HIV vaccine strategies that involve germline targeting and immune-focusing approaches. The company initiated the phase 1 IAVI G002 HIV vaccine trial at the end of January and is partnering to test HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core, which is sponsored by IAVI and supported by the Bill & Melinda Gates Foundation.

The study will enroll 56 healthy, HIV-negative adults across 4 sites across the United States. Of the 56 participants, 48 will receive 1 or 2 doses of mRNA-1644 and 32 of the volunteers will receive the boost Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core).

“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,” William Schief, PhD, professor at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center, said at that time. “What’s more, we’ve been able to expedite production of clinical trial material at a remarkably rapid pace because of Moderna’s technology.”

The development of an effective HIV vaccine has been a long-term goal of research efforts, while other prevention strategies, such as PrEP, have shown promise in decreasing HIV transmission rates when used properly.

“Finding an HIV vaccine has proven to be a daunting scientific challenge,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a press release. “With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection.”

Reference

Moderna Announces First Participant Dosed In Phase 1 Study Of Its HIV Trimer mRNA Vaccine. Moderna. [news release]. March 14, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participant-Dosed-in-Phase-1-Study-of-its-HIV-Trimer-mRNA-Vaccine/default.aspx