The Baltimore-based Institute of Human Virology (IHV) at the University of Maryland School of Medicine launched its Phase 1 clinical trials of a novel HIV vaccine candidate developed by a research team led by Robert C. Gallo, MD, the Homer & Martha Gudelsky Distinguished Professor of Medicine and Director of IHV.


Dr. Gallo’s team includes his IHV co-workers George Lewis, PhD and Anthony DeVico, PhD, and Tim Fouts, PhD of Baltimore-based Profectus Biosciences, Inc., a spinoff company from IHV. Enrollment for the clinical trials began October 1, 2015. The candidate immunogen, denoted as the Full-Length Single Chain (FLSC), is designed to elicit strongly protective antibody responses across the spectrum of HIV-1 strains.

“Maryland is one of the top science, bio-health, and research regions in the country and is home to some of the most brilliant minds in the world,” said Maryland Lt. Governor Boyd Rutherford. “I am especially proud to help announce this first phase of a potential HIV vaccine that is being developed by a talented team at UMD. The Hogan administration will continue to place a priority on supporting the Maryland universities, start-ups, and institutions that are making these groundbreaking discoveries.”

The FLSC is distinguished by its potential ability to induce broad antibody responses to HIV-1. The antibodies induced by the experimental vaccine bind to common HIV regions that are exposed when the virus attaches to target cells, rather than to specific characteristics of the HIV envelope protein that may not be present in all virus strains. This strategy could potentially overcome limitations of previous vaccine candidates that responded to a narrower range of HIV strains.

“Our HIV/AIDS vaccine candidate is designed to bind to the virus at the moment of infection, when many of the different strains of HIV found around the world can be neutralized,” said Dr. Gallo, widely known for his discovery of the first human retroviruses (including one which causes a specific kind of leukemia), co-discovery of HIV as the cause of AIDS, and the development of the HIV blood test. “We believe this mechanism is a major prerequisite for an effective HIV preventive vaccine.”

This study is the first time the FLSC vaccine candidate will be tested in humans following the clinical product development of the vaccine construct led by Profectus Biosciences, Inc. These clinical trials are the next step in a program at the IHV to develop a preventive HIV vaccine funded by the Bill & Melinda Gates Foundation, the U.S. Army’s Military HIV Research Program (MHRP), and other research funding from a variety of sources including the U.S. National Institute of Allergy and Infectious Disease. This Phase 1 trial will be conducted and led by IHV clinicians.

“I’m proud of each member of our group, notably George Lewis, PhD who is director of our Vaccine Research Division, Anthony Devico, PhD, who is a senior researcher in the Vaccine Research Division, and the vaccine team at the Bill & Melinda Gates Foundation,” said Dr. Gallo. “While we still have more important basic research to do to crack the antibody protection challenge, this first step is an important one for us to learn how people (rather than test animals) respond.”