The University of Rochester Medical Center is testing a new method to prevent HIV that scientists hope will boost the development of an effective vaccine for the virus, which infects approximately 2 million people each year, including 50,000 in the United States.
The new study, led by the University’s HIV Vaccine Trials Unit (also known as the Rochester Victory Alliance), will test an experimental antibody against HIV. Traditionally, people get a vaccine and researchers wait to see if they make effective antibodies–proteins produced by our immune system to fight infections–in response to the vaccine. In this study, researchers will skip that step and give people the antibody directly.
The antibody being tested, called VRC01, is able to bind to HIV strains from around the world (there are more than 60 different strains) and block the virus from infecting cells. It has already proven effective in early studies: it prevented animals from getting infected, decreased levels of the virus in HIV infected patients and didn’t produce any negative side effects or discomfort in the more than 100 individuals who have received the antibody so far. It is considered a “broadly neutralizing antibody” because of its ability to neutralize a wide variety of strains of HIV.
Manufactured in a laboratory, the antibody is not made from live HIV, killed HIV, or HIV-infected human cells. It cannot cause HIV infection or AIDS or lead to a positive HIV test. The goals of the study, which hopes to enroll more than 80 participants who are at high risk of acquiring HIV, are to gather more information about the safety of the antibody and to test whether the antibody can prevent HIV infection.
The research community is very excited about the trial, called “AMP”, which stands for “Antibody Mediated Prevention.” Michael C. Keefer, M.D., director of the HIV Vaccine Trials Unit and principal investigator of the study says that it reflects the culmination of five years of intensive laboratory research at the National Institutes of Health and can be a bridge to developing an effective vaccine that makes broadly neutralizing antibodies in people.
“If the VRC01 antibody works to prevent HIV the field will prioritize efforts to design a vaccine that can produce the antibody in sufficient quantities,” noted Keefer. “On the other hand, it is possible that we could find that controlling transmission of the virus might require a vaccine that produces more than one of these broadly neutralizing antibodies. Either way, this study will provide answers that are crucial for timely progress in the field.”
Giving people antibodies to prevent infection is an accepted medical practice that is more than 100 years old. For example, doctors give people natural antibodies to prevent infections like hepatitis A and B and chicken pox. Manufactured antibodies have been used successfully to prevent a dangerous respiratory infection in infants called RSV.
“The AMP study holds promise as a pathway to an HIV vaccine. If it prevents transmission it proves the principle that antibodies are protective, and a vaccine is the next logical step,” said Michael Gottlieb, M.D., associate clinical professor of Medicine at the David Geffen School of Medicine at UCLA. “The University of Rochester has a remarkable track record in HIV research and vaccine development, so it is easy to understand why the University was selected as a site for this important study.”
Gottlieb, who attended medical school at the University of Rochester School of Medicine and Dentistry and completed his residency at UR Medicine’s Strong Memorial Hospital, is one of the most renowned HIV/AIDS specialists in the world. In 1981, he made history when he identified AIDS as a new disease.
Researchers will begin enrolling participants in January 2016 and are looking for healthy, HIV-negative men who have sex with men and transgender individuals who have sex with men who are between the ages of 18 and 50. The antibody is delivered via an IV infusion, which participants will get once every two months. Each participant’s health will be watched closely throughout the study and participants will have access to regular HIV counseling and testing; physical exams; tests for other sexually transmitted infections; and other health and social services.
Nationally and locally, Black men who have sex with men (MSM) are at highest risk for HIV acquisition. LaRon E. Nelson, Ph.D., R.N., co-principal investigator of the trial, says that this research can lead to solutions for reducing disparities among populations that have a high burden of new HIV infections, particularly Black MSM.
“In Rochester we will engage individuals using a holistic, person-centered approach that isn’t typically done in randomized controlled trials,” said Nelson, the Dean’s Endowed Fellow in Health Disparities and assistant professor at the University of Rochester School of Nursing. “For example, we will work with study participants to address some of the social determinants, like housing instability and joblessness, which influence their vulnerability to HIV infection.”
The University of Rochester is one of 19 NIH-sponsored HIV Vaccine Trials Network (HVTN) sites conducting this research in the United States. The research is also being conducted in multiple locations in Africa and South America. The study will enroll and follow about 3,900 participants.
The trial is sponsored by the National Institute of Allergy and Infectious Diseases and was developed by the HVTN and the HIV Prevention Trials Network (HPTN). The Dale and Betty Bumpers Vaccine Research Center, also part of NIH, discovered and manufactured the VRC01 antibody. The University of Rochester Center for AIDS Research (CFAR) will also provide support for the research team’s community engagement activities.