Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Washington Blade - November 22, 2002
Rhonda Smith
"It's very much a personal choice, but I think it's a little thing that we can do to possibly help in a big way," the 27-year-old said of his decision to take part in the study. "I have friends who are HIV-positive, and I've seen the complications and the stress it's caused in their lives."
Worl, who works at a nonprofit organization in Washington, is one of 50 healthy, HIV-negative men and women between the ages of 18 and 40 that researchers at the National Institutes of Health in Bethesda, Md., plan to use in the study's first phase. They have enrolled six volunteers so far and are in the process of recruiting 44 more.
Researchers at the Dale & Betty Bumpers Vaccine Research Center began clinical tests of the HIV vaccine on Nov. 13. The research center is an arm of the National Institute of Allergy & Infectious Diseases (NIAID), an NIH division.
Dr. Anthony S. Fauci, director of the NIAID, said this is the first "multigene and multiclade HIV vaccine" to enter human trials. It marks an important milestone in the center's search for a single vaccine that targets U.S. subtypes of HIV, or clades, he said, as well as HIV strains more prevalent in other parts of the world.
Margaret M. McCluskey and Brenda D. Larkin, research nurses who worked with Johns Hopkins University officials on the Phase III clinical trial of a vaccine known as AIDSVAX, are overseeing the first phase of the Vaccine Research Center's current study. Phase III is the final stage of clinical testing before drug companies can apply for licensing from the U.S. Food & Drug Administration.
The FDA granted VaxGen Inc., a biotechnology company in San Francisco that developed AIDSVAX, permission to start clinical trials on that vaccine in 1998. Results of the study are expected to be unveiled in early 2003.
During Phase I of the Vaccine Research Center's study, which is scheduled to last 12 months, scientists will monitor the vaccine's safety and document whether it induces the desired immune system response in volunteers. Vaccines can cause the immune system to produce antibodies or specific immune blood cells that may suppress or kill infectious organisms that can cause disease.
Vaccine safety addressed
Dr. Barney S. Graham, chief of the Vaccine Research Center's Clinical Trial's Core and lead investigator in the multiclade vaccine trial, said if the vaccine elicits an HIV antibody reaction from a volunteer injected with it, he or she could test positive for HIV by the standard ELISA test that detects antibody to HIV, not HIV itself. This does not mean the participant actually is HIV-infected, he said.
"One certainty is that it is not possible to be infected by the vaccine, which is synthetically produced to mimic shapes and structures on the virus," Graham said.
Other tests, like PRC, could be done to prove a study participant's actual HIV status.
"In terms of health risks, the DNA vaccines have proven to be very safe," Graham said.
The Vaccine Research Center's Web site (www.niaid.hih.gov/vrc) notes, however, that there is the theoretical possibility of more serious side effects or reactions that are unknown at this time. NIAID officials said they monitor volunteers in the study very closely to determine whether they have an adverse reaction to the vaccine.
Researchers will be monitoring Worl and other Phase I participants in the study for arm redness and soreness as well as muscle aches and other mild flu-like symptoms. Participants will receive three injections during the first three months they are enrolled in the study, and then will be monitored monthly for safety checks.
Graham said if the vaccine works as well as it has in studies involving animals, it would advance into larger clinical trials in 2003, during which it would be tested on hundreds of other volunteers. If Phase II of the study succeeds, researchers would begin Phase III trials in 2004, which would involve testing thousands of volunteers with the vaccine.
NIAID officials could know by 2007 whether the vaccine works, Graham said.
Rhonda Smith can be reached at rsmith@washblade.com.
FOR MORE INFO
NIH vaccine trial
1-866-833-5433
TTY: 1-866-411-1010
vrcforlife@mail.nih.gov
www.niaid.nih.gov/vrc
www.clinicaltrials.gov
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