U of R begins trial on potential oral HIV vaccine
By Adam Young
Researchers at the University of Rochester HIV Vaccine Trials Unit are conducting the first study in Rochester of a potential oral HIV vaccine.
The hope is that by delivering the vaccine in pill form via the “mucosal surface” of the mouth, the immune system’s fight will be strengthened from the get-go.
Dr. Michael Keefer, Director of the HIV Vaccine Trials Unit of the Rochester Victory Alliance at the U of R, is one of the doctors leading the study. “The idea is that by delivering it through these capsules we get it to the place where it can create these better immune responses on mucosal surfaces, which is where HIV first encounters the T4 cells when it causes infection in people,” Dr. Keefer said.
The theory behind the oral delivery of the Harvard-developed vaccine is that the capsules can weather the participant’s stomach acid to reach the immune system at a greater depth and not be inactivated by the stomach. The main component of the vaccine, Adenovirus 26, is expected to trigger an immune response from the body that may be capable of combatting HIV. Though the vaccine may cause some “bug”-like symptoms, Dr. Keefer expects the vaccine will produce no serious symptoms in the trial participants. Since the vaccine contains no living or killed HIV, it is impossible to contract HIV from the vaccine.
The study is a “dose escalation” study. Four groups, each consisting of six HIV-negative participants between the ages of 18 and 40, will be under isolated observation at a site at St. Mary’s Hospital. Assuming the first group tolerates the initial dosage with no serious side effects, the dosage will be gradually escalated throughout each remaining group. Participants will be observed and isolated throughout the duration of the study to ensure the vaccine causes no serious symptoms and to prevent the possibility of spreading the Adenovirus to others.
“Our main concern is that [it’s] safe,” Dr. Keefer said. “Effectiveness is the next thing we want to achieve.”
In order to combat the adaptability of HIV, Dr. Keefer stated the vaccine may need to be combined with other types of HIV vaccines to ultimately be effective. The one-two punch approach may be necessary to prevent virus immunity from fading over time. “We need to get the immune response to recognize the three-dimensional structures as opposed to just the linear structures on the virus,” Dr. Keefer said.
After 27 years of preventive HIV vaccine research, Dr. Keefer believes this oral vaccine could be another piece of the puzzle in moving toward a safe, effective HIV vaccine. He is confident the study will go well and it will move on to larger studies, and ultimately licensure studies. “I could see it making a fast track into larger studies. But this is the first thing we have to do and it does take a while to move through these phases of studies,” Dr. Keefer said.
For more information about the work of the Rochester Victory Alliance, visit www.rochestervictoryalliance.org or call (585) 756-2329.