Moderna and the International AIDS Vaccine Initiative (IAVI) administered the first doses of their experimental HIV vaccine on Thursday, marking the beginning of their clinical trial’s first phase.
The biotechnology company teamed up with the nonprofit to develop the new vaccine using so-called messenger RNA, the same novel technology used in making Moderna and Pfizer's COVID-19 vaccines. MRNA works by teaching human cells to produce proteins that trigger immune responses.
"We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna's mRNA platform," said IAVI CEO Mark Feinberg in a statement announcing the program. "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."
This clinical phase aims to test if the vaccine candidate can induce a specific type of white blood cells, known as B-cells, and guide them to create antibodies that have shown in lab results to neutralize a broad range of HIV variants and protect humans against infection. Those proteins are "widely considered to be the goal of HIV vaccination, and this is the first step in that process,” according to Moderna.
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The Phase I trial will enroll 56 healthy and HIV-negative adult participants at George Washington University School of Medicine and Health Sciences in Washington, D.C., and at three other sites: Hope Clinic of Emory Vaccine Center in Atlanta, Georgia; Fred Hutchinson Cancer Research Center in Seattle, Washington; and the University of Texas-Health Science Center at San Antonio in Texas.
Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, with 32 of them also receiving a booster shot. The other eight participants will only receive the booster.
Researchers will then monitor participants for safety and efficacy of the experimental vaccine for six months after their last dose.
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Despite years of research, several HIV vaccine candidates that entered clinical trials failed in later stages. The National Institute of Health is currently investing in two multinational vaccine trials that are in Phase II and Phase III of studies in Africa.
Over 37 million people around the world – including an estimated 1.1 million in the U.S. – are living with HIV, or human immunodeficiency virus, according to the United Nations Programme on HIV/AIDS. Nearly 15,000 patients in the United States die from the disease every year, data from the Centers for Disease Control and Prevention shows.
Although the disease has no effective cure, people living with HIV today are able to suppress their viral loads to undetectable thanks to developments in modern medicine. FDA-approved oral treatments can reduce the amount of HIV in the blood so the virus can't be transmitted.