This is the first HVTN trial to be conducted simultaneously in the U.S. and abroad, and it signifies a dedication to transcending borders in the fight against HIV. This vaccine has never been tested in humans.
"Scientists want to know more about this candidate vaccine because it seems to have the ability to make the immune system respond in ways that could help the body fight HIV," said Geoffrey Gorse, M.D., from Saint Louis University School of Medicine, the lead researcher on this international study. "This trial is called a phase I trial, which means that it will test to see that the vaccine candidate is safe and that it has an effect on the human immune system."
The trial is being conducted simultaneously in St. Louis, Boston (through Harvard University) and Gaborone, Botswana.
The trial is looking at the safety and immune response of an experimental HIV Vaccine called EP HIV-1090, known as a 'DNA plasmid' type of vaccine, said Dr. Sharon Frey, the principal investigator on the trial at the Saint Louis University site.
"The vaccine is not produced from live virus or from infected human cell lines, so there is no possibility that its contains live or killed HIV virus," Frey said. "Therefore, it is not possible for someone to get HIV infection or AIDS by receiving this vaccine."
While several HIV vaccine trials have been undertaken by the HVTN in a range of countries, those studies have always followed a U.S. trial. This time participants are receiving the same injections during the same time period at all three sites.
The trial will last 18 months, with the injections received over a six-month course, followed by a year of observation. Forty-two people will be enrolled in the trial, with 36 receiving the candidate vaccine and six people getting a placebo.
"This study is an important step in understanding this vaccine candidate and whether it should be considered for a larger, phase II trial," Frey said.
This trial is the HVTN's first African trial, involving some of the communities most impacted by AIDS in the development of an HIV vaccine. Africa, and in particular Southern Africa, has been devastated by AIDS. The trials in Botswana will be conducted through the Botswana-Harvard Partnership for HIV Research and Education, based in Gaborone, Botswana.
"This vaccine candidate represents an important approach now under investigation," Gorse said. "Moving any key candidate into human trials is vitally important to developing an HIV vaccine."
There are several HIV vaccine candidates currently in trials or soon to begin trials. Any or all of these may help us move closer to finding a vaccine for HIV.
Other possible vaccine candidates continue to be developed, and the HVTN will continue to carefully evaluate candidates and conduct new trials. The experimental vaccine in this study was developed by researchers at Epimmune Inc. in San Diego.
The process for finding an HIV vaccine is expected to take time. Most likely, there will be many trials, and many different vaccine candidate variations will need to be explored.
To learn more about these studies, call the HIV Vaccine Trials Unit at Saint Louis University at 314-268-5448.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.