The groundbreaking study begins later this month.
Starting in September, Moderna will be undertaking clinical trials of an HIV vaccine that's grounded in mRNA technology—similar to its COVID-19 vaccine that's currently pending full FDA approval. With approximately 1.2 million Americans currently diagnosed with HIV, positive results during Moderna's clinical testing have significant implications for how the virus can be treated in the future.
Although Moderna's COVID-19 vaccine is not the only treatment to use mRNA technology, it's brought this type of vaccine to the limelight. These vaccines use a slightly different approach than traditional ones, but the end goal is ultimately the same: to teach the human immune system how to fight off viruses before they've had enough time to replicate into a full infection.
Whereas most vaccines will generate an immune system response by placing a weakened or inactive germ into a patient's bloodstream, mRNA vaccines instead teach cells to make a single type of protein. This protein is an incomplete but significant part of the virus, and in producing it, the body's cells understand how to mount an effective immune system response.
For example, Moderna's COVID-19 vaccine works by creating a small replica of the spike protein—the main tool that COVID-19 pathogens use for infecting cells—and conditioning the immune system to avoid and dismantle it.
Meanwhile, Moderna's HIV vaccine works similarly, by teaching the immune system to make inert proteins of the virus so that it can better fight off and potentially entirely prevent infections. These trials are designed to test if the vaccine is capable of producing an immune system response in humans and if so, whether this response comes with a lower risk of infection.
In previous trials, this mRNA vaccine was shown to be effective in primates, clearing the way for trials involving humans—the next step on a long road towards official FDA approval. To this end, Moderna's first stage of human clinical trials will consist of 56 participants between the ages of 18 and 56 who do not have HIV. The groups will be divided into four groups, with each one receiving a different dosage and regimen of the vaccine. At the end of the trial window, blood samples will be tested for an immune response to lab-cultivated HIV cells, meaning that the participants are never at any risk of conducting it from the study.
The Phase I trial is expected to last through May 2023. If trial data shows a promising immune system response, Moderna will then likely move on to larger-scale testing among additional volunteers. Among Moderna's many academic partners in this study are the University of Texas at San Antonio, Emory University, George Washington University, and the Fred Hutchinson Cancer Research Center.
Approximately 38 million people currently live with AIDS worldwide today, and tens of millions more have had their lives impacted by it in some fashion. If this vaccine proves effective, experts hope that it could translate to an end—or at least a sizable decline—of the epidemic.
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