Moderna, Inc. announced that the first participant has been dosed in a clinical trial of an experimental HIV trimer mRNA vaccine (mRNA-1574).

Stephen Hoge, MD, president of Moderna, stated, "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. 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. This study is another step in our fight against HIV, as well as other latent viruses such as our recently launched studies in CMV [cytomegalovirus] and EBV [Epstein-Barr virus]."

The open-label, multicenter, randomized, phase I trial (HVTN 302) is designed to assess the safety and immunogenicity of experimental HIV trimer mRNA vaccines. The primary hypothesis is that the soluble and membrane-bound HIV envelope trimer mRNA vaccines will be safe and well-tolerated by HIV-uninfected individuals and will elicit autologous neutralizing antibodies. The trial is expected to enroll approximately 100 HIV-negative adults aged 18 to 55 years.

Dr. Larry Corey, principal investigator, HIV Vaccine Trials Network Leadership Operations Center, which is based at the Fred Hutchinson Cancer Research Center, stated, "It is gratifying to see that the experience with mRNA as a critical COVID-19 vaccine platform is now entering the HIV vaccine field. We are optimistic that this study will pave the way for continued approaches for using mRNA in HIV."

The trial is sponsored and funded by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health. The envelope trimers being assessed in this study were developed by William Schief, PhD, and colleagues. Dr. Schief is a professor at Scripps Research and executive director of vaccine design at International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center. Development of the native-like HIV trimers and manufacture of the HIV trimer mRNA vaccine was funded by an NIAID (DAIDS) Consortium for HIV/AIDS Vaccine Development grant to Scripps Research.

Moderna is currently advancing two HIV-preventative vaccine strategies based on germline targeting and immune-focusing approaches. In addition to this HIV trimer mRNA vaccine trial, Moderna is partnering in testing of HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core, which are being evaluated in a phase I trial sponsored by IAVI.

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