January 03, 2005
Trial is expected to begin in January 2005
NEW YORK -- The Aaron Diamond AIDS Research Center (ADARC), an affiliate of The Rockefeller University, and the International AIDS Vaccine Initiative (IAVI) have begun recruiting volunteers for an upcoming human clinical trial of a new investigational vaccine to prevent HIV infection and AIDS. The trial, which is expected to begin in January 2005, seeks healthy volunteers aged 18-40 in New York City and Rochester, New York.
This phase I research study will last 18 months and is designed to evaluate the safety and immune system effects of a vaccine candidate called ADMVA. Developed by scientists at ADARC, the vaccine candidate is based on Modified Vaccinia Ankara (MVA), a vaccine that was used as part of a global smallpox eradication program in the 1970s. The ADMVA vaccine candidate is designed to stimulate immune responses to prevent people who are not infected with HIV/AIDS from contracting the disease.
If ADMVA performs well in initial tests, it can advance to larger trials in other regions. ADMVA is modeled after the C strain of HIV, which is prevalent in China, India, and Sub-Saharan Africa and accounts for more than 50 percent of new HIV infections worldwide. A successful vaccine would potentially save millions of lives each year. If ADMVA proves effective, ADARC and IAVI are committed to ensuring that it is made available in developing countries at affordable prices.
“With each passing year, the grip of the disease tightens worldwide as the disease makes new inroads into heavily populated regions in Asia,” said Dr. David Ho, Director and CEO of ADARC and Rockefeller University’s Irene Diamond Professor. “Developing an effective AIDS vaccine is one of the greatest challenges researchers and volunteers have ever faced. But the rewards in terms of lives that could be saved by an effective vaccine are also among the greatest in human history.”
“A preventive vaccine offers the best hope for controlling the epidemic,” said Dr. Seth Berkley, President and CEO of IAVI. “We are hopeful that ADMVA will bring us closer to an effective vaccine.”
According to UNAIDS, approximately 13,000 people are infected with HIV worldwide each day.
“Scientific progress to develop an effective AIDS vaccine cannot be achieved without the participation of volunteers in vaccine trials,” said Mitchell Warren, the Executive Director of The AIDS Vaccine Advocacy Coalition (AVAC). “By volunteering, participants are making a vital contribution to the vaccine development process.”
Regulatory clearance to conduct the trial was granted by the Food and Drug Administration on December 20, 2004. The ADMVA vaccine candidate does not contain any material from live HIV, blood or blood products, or materials from individuals who are infected with HIV. It is not possible to get HIV infection from ADMVA.
The trial will enroll approximately 48 healthy male and female volunteers ages 18-40 over the coming months. Study participants must be healthy, HIV-negative, and at low risk of HIV infection. In addition, volunteers must plan not to become pregnant or impregnate a partner during the trial and for four months after the last vaccination. Participants will be randomly assigned to receive either the vaccine candidate or an inactive solution known as a placebo. Volunteers will visit the outpatient clinics (in either The Rockefeller University Hospital in New York City or the University of Rochester Medical Center) 12 times over 18 months.
For information about enrolling in the ADMVA trial, contact Elizabeth Londoño of ADARC at 212-448-5125 or at email@example.com
About ADARC and The Rockefeller University
Establishd in 1991, the Aaron Diamond AIDS Research Center (ADARC) is the world’s largest private research laboratory devoted solely to biomedical research on HIV/AIDS. Under the direction of Dr. David Ho, ADARC has played an important role in research that has helped advance scientific understanding of HIV and improve clinical care for people with HIV/AIDS. ADARC is affiliated with The Rockefeller University, whose hospital, the first clinical research hospital in this country, created the setting for a new kind of scientist: the clinical investigator who serves as a link between the practicing physician and the basic scientist.
The Rockefeller University is a world-renowned center for research and graduate education in the biomedical sciences, chemistry, bioinformatics, and physics. Founded by John D. Rockefeller in 1901 as the nation’s first institute for medical research, the university has a unique laboratory-based structure that encourages interdisciplinary research and collaboration. The university has dedicated its second century to translating the insights gained from genomics and molecular biology advances to improving public health.
The International AIDS Vaccine Initiative (IAVI; www.iavi.org) is a global not-for-profit organization working to accelerate the development of a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI also works to assure that a vaccine will be accessible to everyone who needs it. IAVI’s major financial supporters include the Bill & Melinda Gates Foundation; the Rockefeller, Sloan and Starr foundations; the World Bank; BD (Becton, Dickinson & Co.); the European Union; and the governments of Canada, Denmark, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States.
About the University of Rochester Medical Center
With more than $122 million in NIH research grants, the University of Rochester Medical Center ranks in the top one-fifth of all medical centers in federally funded research. A bold, 10-year endeavor has resulted in two new research facilities and the recruitment thus far of 70 new scientists and 500 technicians and support personnel. Michael C. Keefer M.D., Principal Investigator for the HIV Vaccine Trials Unit, has been conducting preventive HIV vaccine research studies at the university since the world’s first in 1988. More than 800 local HIV-negative citizens have volunteered to participate in these studies.