HIV Vaccine Trial Utilizing mRNA Underway

Before the COVID-19, Moderna was a company known only to a handful of people in the biotech industry and those who follow its doings. Now as one of the three companies that produced a COVID-19 vaccine that received an OK from the FDA, the company has become a household name.

But Moderna has a broader portfolio than just the COVID-19 vaccine. The company, headquartered in Cambridge, Massachusetts, announcing that recently that it had launched a trial of an HIV vaccine that uses the messenger RNA (mRNA) technology that the company harnessed to make its COVID-19 vaccine.

Experts have commented that the use of mRNA technology is a major development in the marathon efforts to develop an HIV vaccine that have not yet yielded a real-world-ready vaccine. The pursuit of vaccine goes back decade; NIH conducted the first vaccine clinical trial in 1987.

Moderna took to social media and posting on its own website on Jan.27 to announce the launch of the phase1 study, which is called IAVI G002 and its clinicaltrials.gov number is NCT05001373. The immunogens that the vaccine uses were initially identified by researchers at IAVI (the International AIDS Vaccine Initiative) and Scripps Research, a research institute in La Jolla, California, led William Schief, Ph.D.

“Phase I of the trial has already begun; the participants received their doses at George Washington University School of Medicine and Health Sciences in Washington, D.C.,” the company announced. “The vaccine works in a way similar to Moderna’s successful COVID-19 vaccine, leveraging messenger RNA to teach the cells to develop and trigger proper immune responses against the virus.”

The first phase involves 56 healthy individuals who are adults and have not been infected with HIV. The research will be carried out at GWU as well as The Hope Clinic of Emory Vaccine Center in Atlanta, the University of Texas-Health Science Center at San Antonio, and the Fred Hutchinson Cancer Research Center in Seattle.

IAVI, which is headquartered in New York, is a nonprofit organization that supports research into vaccines for HIV and other diseases. The organization’s long list of supports include U.S.

federal government health organizations, government health organizations in a number of other countries and major philanthropic organizations, such as the Bill and Melinda Gates Foundation.

The IAVI press release about the phase 1 vaccine trial said it is designed to test hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development. “The induction of bnAbs is widely considered to be a goal of HIV vaccination, and this is the first step in that process,” the IAVI press release said,

According to the Moderna press release, the trial is designed to involve a total of 56 volunteers, all of whom will be HIV negative. Thirty-two will receive one or two doses plus booster, 16 will received just one or two doses, and eight will receive just the booster.

The participants will be closely monitored for side effects for six months after their last dose. Researchers will also assess the immune responses to the vaccine.

“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Mark Feinberg, IAVI’s president and CEO, said in IAVI press release. “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.”