The University of Texas Health Science Center at San Antonio and clinical partner University Health soon will begin a Phase 1 clinical research study of an HIV vaccine candidate produced by Moderna. This will be San Antonio’s first-ever study of an mRNA HIV vaccine.
The study, which will enroll up to 15 patients locally, is sponsored by IAVI, a global nonprofit scientific research organization. UT Health Science Center San Antonio, University Health, the Fred Hutchinson Cancer Research Center, George Washington University and Emory University are the trial sites, and Moderna is providing the vaccine. The Bill & Melinda Gates Foundation helped fund the vaccine candidate research.
“We seek healthy volunteers who are passionate about contributing to the science of developing an HIV vaccine,” said local principal investigator Barbara Taylor, MD, MS, assistant dean and associate professor of infectious diseases at the health science center’s Joe R. and Teresa Lozano Long School of Medicine. Dr. Taylor is also a clinician treating patients at University Health. Volunteers will be enrolled for durations ranging from six to 11 months depending on the arm of the study to which they are randomized. They will be compensated for their time. Outpatient examinations and blood analysis will be conducted at University Hospital to measure the effects of the vaccine.
“The strategy under study involves two mRNA vaccines, one a prime and one a boost,” Dr. Taylor said. “IAVI already completed a first-in-human trial with a protein-based version of the prime. The second shot, the boost, is being tested for the first time in humans in our study.”
The goal of the San Antonio site’s study is to demonstrate safety of the mRNA-delivered priming and booster dose of the HIV vaccine candidate. The study is evaluating the immune response to different parts of the vaccine, specifically the development of responses that could create broadly neutralizing antibodies (bnABs). The ultimate goal is the development of a series of vaccine candidates that prevent human immunodeficiency virus (HIV) infection. A globally effective HIV vaccine could lower infection rates and prevent illness and deaths from the disease caused by HIV, acquired immunodeficiency syndrome (AIDS).
No one at risk for HIV will be enrolled, and no pregnant women can be included.
The COVID-19 pandemic has shown the safety and effectiveness of messenger RNA vaccines. Sort of like a recipe does for a chef, these vaccines provide instructions (mRNA) to the body’s cells on how to make a harmless protein. The resulting protein particle stimulates an immune response. Once the particle is made, cells delete the mRNA instructions, but the immune response, now learned, remains.
“For many of us, one of the few bright lights of the COVID-19 pandemic has been the demonstration of the utility of mRNA technology,” Dr. Taylor said. “We’ve seen it work for COVID and it has been truly amazing, but it doesn’t have to stop at COVID. We can take this new strategy and apply it to an unfortunately old and hard-to-crack problem, HIV.”
For more information and to volunteer, visit UTHealthResearch.com or call 210-469-3206.