CAMBRIDGE, Massachussets — Moderna has launched early-stage human trials for an mRNA vaccine to treat HIV, the company announced to investors on Thursday.
In a news release for company investors, the biotechnology company announced that has administered the first doses in a Phase 1 trial of HIV vaccine antigens at the George Washington University School of Medicine and Health Sciences in Washington, D.C.
The trial, conducted in partnership with the nonprofit International AIDS Vaccine Initiative, is designed to test whether the vaccine, which delivers HIV immunogens via messenger RNA (mRNA), can cause the body's B-cells to develop antibodies that can protect against the virus.
The immunogens being tested in the trial were developed by teams at IAVI and Scripps Research. The vaccine uses the same mRNA technology developed by Moderna for its COVID-19 vaccine.
"We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna's mRNA platform," said Dr. Mark Feinberg, president and CEO of IAVI. "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."
The trial will be conducted at three additional sites, the Hope Clinic of Emory Vaccine Center in Atlanta, Georgia, the Fred Hutchinson Cancer Research Center in Seattle, Washington, and the University of Texas Health Science Center in San Antonio, Texas.
Each of the four sites will enroll 56 healthy, HIV-negative adult volunteers. 48 of those will receive one or two doses of the vaccine, with 32 of those volunteers being given the booster shot. An additional eight volunteers will be given the booster by itself. Volunteers will then be monitored for six months after the last dose, with their immune responses being analyzed at the molecular level.
This trial is a follow-up to a proof-of-concept trial conducted in 2021 conducted by William Schief, Ph.D., a professor with Scripps Research and the executive director of vaccine designed at IAVI's Neutralizing Antibody Center.
Results from that trial found that a version of the priming immunogen induced the desired B-cell response in 97% of trial recipients. The focus of the new trial is to test the priming of the immune response and the abilities of a boosting immunogen to induce further maturation of B-cells into ones that produces the HIV-specific antibody.
HIV, which stands for human immunodeficiency virus, is a virus that attacks the bodies immune system. If left untreated, it can lead to Acquired Immunodeficiency Syndrome, or AIDS.
According to data from UNAIDS, 3.7 million people were living with HIV in 2020, which includes 1.7 million children. 53% of the total were women and girls.
