The Hope Clinic of the Emory Vaccine Center today announced that the Step Study, a multicenter international study of an HIV vaccine developed by Merck and Co., Inc., has successfully enrolled more than 2,800 people and expects to finalize enrollment within the next few months.
Cosponsored by the HIV Vaccine Trials Network (HVTN), the study plans to fill 200 slots at the participating sites in North and South America, the Caribbean and Australia.
"We have been very pleased with the depth of support for the Step Study that we have seen in Atlanta," says Carlos del Rio, MD, principal investigator for the Step Study at Emory. "Our community is well aware of the need for a vaccine against HIV and has demonstrated its commitment by stepping forward to volunteer for the study."
The study has enrolled volunteers who are HIV negative and generally healthy, but who have certain risk factors for HIV. The vaccine candidate used in this study has generated strong and durable cellular immune responses against HIV in early human trials.
According to UNAIDS, nearly 46 million people were living with HIV in 2006. With more than 11,000 new HIV infections each day, 95 percent of which occur in developing countries, the global epidemic shows no sign of abating. UNAIDS has reported that a record 2.9 million people died of AIDS in 2006.
As with other infectious diseases, development of a vaccine is recognized as the best long-term hope to end the AIDS pandemic. Vaccines are a critical part of an integrated strategy to fight HIV infection, which also includes treatment and prevention.
The Step Study is a collaboration of Merck & Co., Inc., the HVTN, and the National Institute of Allergy and Infectious Diseases (NIAID), which funds and supports the HVTN. It combines Merck's vaccine research efforts and clinical trials expertise with the clinical trials experience and global capacity of the HVTN.
The study is a multicenter, randomized, double-blind, placebo-controlled Phase II trial of about 3,000 male and female volunteers ages 18 to 45 of diverse racial groups who are at high risk for contracting HIV. All study participants have received counseling about how to reduce their risk of HIV infection.
The vaccine candidate, known as the MRKAd5 HIV-1 gag/pol/nef, or trivalent, vaccine, is based on adenovirus, a common cold virus that has been modified so that it cannot reproduce and cause a cold in humans. The adenovirus is used as a vector, or a delivery vehicle, to transport three synthetically produced HIV genes--gag, pol and nef--into cells. These genes stimulate the body to generate a potent cellular immune response to HIV, producing an army of killer T cells programmed to recognize and kill HIV-infected cells. No live HIV is used in the production of the vaccine candidate, so the vaccine candidate cannot cause HIV infection or AIDS. About The Hope Clinic of the Emory Vaccine Center
The Hope Clinic, located in downtown Decatur near the Emory University campus, was created in 2002 to conduct clinical trials of promising new vaccines and therapeutic interventions for challenging infectious diseases. The Emory Vaccine Center, part of the Yerkes National Primate Research Center and Emory University School of Medicine, was established in 1997 and is home to one of the nation's largest and most respected basic and preclinical vaccine research programs. The Hope Clinic has become one of the leading clinical vaccine trial sites in the country.
About the HIV Vaccine Trials Network
The HVTN is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company.
Working with industry and government, the HVTN seeks t o expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. The HVTN is funded and supported by the NIAID of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS).
The HVTN comprises more than 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle.