The Moderna Laboratory has begun the so-called phase 1 trial stage of an HIV vaccine using messenger RNA technology in the United States, on 56 uninfected adults, both the biotech company and the International AIDS Vaccine Initiative (IAVI) announced Thursday.
The first participants were injected Thursday at George Washington University School of Medicine and Health Sciences in Washington, D.C., according to a company statement. The laboratory has teamed up with the nonprofit IAVI to develop the drug, which uses the same technology as Moderna's successful 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, in a statement. 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.
Nearly 38 million people worldwide are living with HIV, or human immunodeficiency virus, which can lead to the potentially fatal disease AIDS. Being diagnosed with HIV in the 1980s and early 1990s was considered a death sentence. With today's medication, HIV can be handled as the drugs can reduce viral loads to undetectable levels in a way that the virus cannot be transmitted. But despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.
The new vaccine uses messenger RNA, which teaches the body's cells how to make proteins that trigger immune responses. Researchers have developed not only a primary vaccine but also a booster to deliver HIV immunogens. The hope is this process can induce specific white blood cells to turn into broadly neutralizing antibodies.
According to a Moderna statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.
Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster. Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.
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