Moderna Begins its Phase 1 HIV Trimer mRNA HIV Vaccine Trial

Moderna announced yesterday it had begun its second phase 1 HIV vaccine trial in just a matter of weeks.

This latest phase 1 trial is an open-label, multicenter, randomized study (HVTN 302), and will evaluate the safety and immunogenicity of their experimental HIV trimer mRNA vaccine (mRNA-1574). The trial is expected to enroll approximately 100 HIV-negative adults, aged 18 to 55 years.

Moderna has been using it mRNA vaccine technology platform to develop vaccines 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," Stephen Hoge, MD, president of Moderna, said. "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."

2 HIV Vaccine Strategies, Studies

Moderna has developed 2 HIV vaccine strategies using germline targeting and immune-focusing approaches. In addition to this aforementioned phase 1 study, Moderna announced it began its phase 1 IAVI G002 HIV vaccine trial at the end of January. The company is partnering in testing of HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core, which this trial is sponsored by IAVI and supported by the Bill & Melinda Gates Foundation.

This study will enroll 56 healthy, HIV-negative adult volunteers across 4 sites across the United States. Of the total number of participants, 48 will receive 1 or 2 doses of eOD-GT8 60mer mRNA Vaccine (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 a successful HIV vaccine has long alluded researchers, and public health has used other prevention strategies such as PrEP to decrease HIV transmission rates. 

However, there has been a flurry of activity and study in this area recently utilizing the mRNA technology platform. “Finding an HIV vaccine has proven to be a daunting scientific challenge,” Anthony Fauci, MD, NIAID director, said in a statement. “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.”