Moderna's mRNA HIV Vaccine Trial Accepts Miami Beach Man

Moderna has begun phase 1 human trials on experimental mRNA vaccines to prevent HIV.
Moderna has begun phase 1 human trials on experimental mRNA vaccines to prevent HIV. Photo by Marco Verch/Flickr
Following the historic success of Moderna's mRNA COVID-19 vaccine, the pharmaceutical giant is set to begin phase 1 human trials on another groundbreaking mRNA vaccine: for human immunodeficiency virus (HIV). Among the trial's 56 participants from across the nation — all of whom are HIV negative, and in good, general health — is Miami Beach resident Ernesto Orsetti, an openly gay man.

"Being part of this research for me is very important," Orsetti tells New Times. "This is important research, especially for the LGBTQ community."

Last month, Moderna posted its mRNA HIV vaccine study record on the Health Clinical Trial registry at the U.S. National Library of Medicine, stating that researchers had begun enrolling participants and randomly divvying them into four groups. Two mRNA treatments are being studied: Core-g28v2 60mer and eOD-GT8 60mer. Each participant, depending on the group, will have one or both treatments injected. Similar to the COVID-19 vaccine, the idea is that the injection(s) will prompt the immune system to create specific antibodies (bnAb) that will neutralize HIV if and when a participant becomes infected.

Though Moderna's HIV vaccines are far from the first try at an HIV vaccine, experts and industry observers say this clinical trial is significant, in that it's the first attempt to prevent HIV using mRNA technology — the same technology that was successfully used in humans for the first time with Moderna's and Pfizer/BioNTech's vaccines to prevent COVID-19.

The FDA states that these studies "are used to determine whether there are adverse reactions with increasing doses and, if possible, to gain early information about how well the vaccine works to induce an immune response in people."

It was not immediately clear whether anyone had received their first inoculation as of Thursday, and Moderna representatives did not return emails and phone calls from New Times. Orsetti says his vaccination date has been scheduled.

He says he was part of a COVID-19 vaccine study in 2020 and that he was asked by researchers earlier this month to participate in this study. He was notified that he was accepted into the study earlier this week.

"I am not afraid to receive the injection," Orsetti adds. "It's an opportunity to face another challenge."

HIV attacks the immune system and ultimately prevents it from being able to fight off infection and, if untreated, progresses to Acquired Immunodeficiency Syndrome (AIDS). The epidemic has remained persistent over the past four decades since it was first recorded in the U.S. in 1981 and has killed more than 36 million people worldwide.

HIV affects nearly 30,000 people in Miami-Dade County, which has one of the highest rates of new HIV infection in the nation. Earlier this year, the Centers for Disease Control and Prevention (CDC) reported that Florida has more new HIV cases than any other U.S. state.

Though no cure exists, HIV is highly treatable and those living with a diagnosis can receive antiretroviral therapies that stop the virus from progressing to AIDS and prevents it from being transmitted to others.

The new Moderna study is sponsored by the International AIDS Vaccine Initiative and also involves the University of Texas at San Antonio, the Fred Hutchinson Cancer Research Center in Seattle, Emory University in Atlanta, and George Washington University in Washington, D.C. The record for this phase of the vaccine trial shows that the study is projected to conclude in May 2023.
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Michael Majchrowicz is a former staff writer at Miami New Times. He studied journalism at Indiana University and has reported for PolitiFact, The New York Times, Washington Post, the Post and Courier, and Tampa Bay Times.