ATLANTA, Georgia (Observer Update) - GeoVax Labs announced the first injections in its Phase IIa human clinical vaccine trial for its candidate HIV vaccine. The trial, designated HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN), which is funded and supported by the National Institute of Allergy and Infectious Diseases.
The HVTN has sponsored over 80 Phase I trials for the initial evaluation of safety and immunogenicity of candidate HIV vaccines. The results of these trials have merited only five Phase IIa trials since 1992. GeoVax is pleased to report that the first injections for its Phase IIa trial were conducted at the HVTN network sites at the University of Alabama–Birmingham and Nashville’s Vanderbilt University. The trial will include a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients) and take place at 13 HVTN sites: 11 in North America and two in South America. Sites in the United States include Emory University in Atlanta; Harvard Medical School in Boston; Vanderbilt University; the University of Rochester in Rochester, N.Y.; the Fred Hutchinson Cancer Research Center in Seattle; the San Francisco Department of Public Health; the University of Alabama–Birmingham; and Columbia University in New York City. In South America, participants are to be enrolled in Peru at sites in Iquitos and Lima.
"I am extremely pleased that our vaccine merited moving forward through the HVTN," Harriet Robinson, Ph.D., developer of the vaccine and senior vice president of research and development at GeoVax, says in a press release. "This network provides a wide array of support for its clinical trials, from finances to statistical design and analysis; from community engagement to rigorous laboratory analysis. Working with the HVTN also affords us the input of the NIAID Prevention Science Research Committee, a committee with breadth of experience and knowledge in human vaccine development." ...
MONTREAL, Quebec - Two studies presented at the recent 16th Conference on Retroviruses and Opportunistic Infections showed no benefit for HIV patients given a cancer drug designed to create immune cells, reported HIV Plus Magazine.
While earlier results showed promise, patients treated with Novartis’s interleukin-2 (Proleukin) fared no better than patients who did not receive the drug. “As far as I’m concerned, this is the end of interleukin-2 for HIV,” John Bartlett, a Johns Hopkins University AIDS researcher who was not involved with the studies, told Bloomberg News. Interleukin-2 is a cytokine, a chemical that occurs naturally in the body and activates the immune system. It is approved to treat skin and kidney cancers. The two trials examined whether it would be of benefit to patients on antiretroviral regimens.
A $65 million National Institutes of Health–funded study looked at interleukin-2’s effect on 4,011 people who began treatment with CD4-cell levels higher than 300 per cubic millimeter of blood. The second study involved 1,695 patients who started with CD4-cell counts of 50 to 299. U.S. guidelines recommend that antiretroviral treatment begin when CD4 levels drop below 350. While the drug raised immune cell levels in both trials more than researchers expected, death and illness rates were the same in treated and untreated groups, Marcelo Losso of the Hospital Jose Maria Ramos Mejia in Buenos Aires, who presented the results, told Bloomberg News. In the study of people who began with CD4-cell counts of more than 300, serious side effects were more common among those who received interleukin-2, he said.
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