Individuals who are not infected with the HIV virus but who may be at risk of infection because of sexual or drug-related behaviors may be eligible to participate in a new Atlanta trial of an investigational HIV vaccine sponsored by Merck, Inc. and the National Institutes of Health (NIH).
"With over 5 million new HIV infections and over 40,000 new cases in the U.S. each year, finding an effective vaccine should be the number one public health priority for the world today," according to Carlos del Rio, MD, executive director of the Hope Clinic of the Emory Vaccine Center. "By being involved with the study, the public will have an important role in this critical effort."
The Hope Clinic is seeking individuals with specific risk factors for acquiring HIV and AIDS to participate in a Phase IIB clinical trial of an HIV vaccine developed by Merck, Inc. This is the first time Emory and the Hope Clinic have participated in a clinical trial that tests an HIV vaccine in at-risk individuals.
"This trial is important for Atlanta, since it's the first opportunity for both men and women from high-risk populations here to participate in testing a vaccine to see if it will prevent HIV, or if infected while the study is going on, whether it will reduce HIV in the blood," Dr. del Rio explains. "The Hope Clinic will be working with other HIV/AIDS education and prevention groups to spread awareness about the trial and make sure we include people from the populations most affected by HIV in Atlanta."
The clinical trial will include 1,500 volunteers worldwide, including approximately 60 who will be enrolled at the Hope Clinic. Initial administration of the vaccine and follow-up blood tests will take place over 18 months, and volunteers will be followed to five years. Volunteers for the clinical trial must be between 18 and 45 years of age and must test negative for the HIV virus. Male volunteers who have had sex with men must have participated in risky sexual behavior within the past six months. Female volunteers must have participated in risky sexual behaviors and/or risky drug-related behaviors.
Walter Orenstein, MD, associate director for strategic planning at the Hope Clinic adds, "This study is important because it will test not only whether this vaccine can be safe and effective but also can pave the way for development of many other vaccines that can act in a similar way."
Over the past three years Emory's Hope Clinic has conducted Phase I clinical trials of Merck-developed vaccines in healthy individuals not at risk for developing HIV. A Phase I clinical trial already has been conducted to test the safety of the current Merck-developed investigational vaccine. The Phase IIB trial will also assess the vaccine's ability to stimulate immune responses against HIV. Participants will not be exposed to the HIV virus as part of the clinical trial.
The Hope Clinic is a world-class leader in clinical investigation of vaccines and disease-prevention strategies. It is located in downtown Decatur at 603 Church St. For more information about the clinical trial, please call 404-377-3719 or 1-877-424-HOPE.