Volunteers needed for HIV vaccine trial

Researchers looking for men, trans women who have sex with men to participate in study

Gallegos.Ernesto

Ernesto Gallegos

DAVID TAFFET  |  Staff Writer
taffet@dallasvoice.com

UT Southwestern continues recruiting volunteers to participate in a vaccine trial that has been in progress for more than a year.

The Phase II trial is taking place at almost two dozen sites across the country. According to Clinical Research Unit Community Advisory Board member Ernesto Gallegos, Dallas has been among the most successful at recruiting volunteers — but more qualified participants are needed.

Researchers are looking for healthy adult men who test HIV negative, have sex with other men, are between the ages of 18 and 50 and are circumcised.

They are also seeking transgender women who have sex with men.

Volunteers are screened to make sure they qualify for the trial.
Gallegos said participating would be a 12-to-18-month commitment.

He said his involvement began when he volunteered for the study.

He had a partner who was positive.

In his initial screening, he was disqualified because he had antibodies to the adenovirus type 5. That common virus is a cause of respiratory illnesses.

Gallegos said that when he learned he couldn’t participate directly in the study, “I stepped back [and asked], ‘How can I continue to help?’”

That’s when he joined the advisory board as its youngest member.

Volunteers receive a physical exam and, if they are accepted into the project, they are administered the vaccine in four doses.

Participants are asked to keep a written record of any reaction to the vaccine and are required to go to UT Southwestern once every three months for an HIV test, an interview and risk reduction counseling.

A participant cannot contract HIV from the vaccine because it does not contain the virus itself. It is not made from live, weakened or killed HIV or HIV-infected cells.

Phase I of the trial established that the vaccine was safe to give to humans. This phase continues to test safety and dosages.

Researchers will be looking at whether the group getting the vaccine has less chance of contracting the virus and if those who do contract the virus will show smaller amounts of HIV in the blood.

Half the test group will receive the vaccine and half a placebo.

Volunteers will not know whether they received the placebo or the vaccine until after their participation in the study is complete.

Those who are inoculated with the placebo will be eligible to participate in future vaccine studies. Generally those who got the actual vaccine are ineligible for future studies, whether the vaccine proved efficient or not.

For more information or to volunteer, go online to HopeTakesAction.org and fill out a short questionnaire or call 214-590-0610.

This article appeared in the Dallas Voice print edition January 13, 2012.

UPDATE: UT Southwestern Clinical Research Manager Tiana Petersen wrote to update a few items in the story. She said participants would commit 24 months to the study. The Adenovirus type 5 is a common cold virus.

“Phase IIB, is specifically designed to study efficacy,” she wrote. “Researchers will evaluate whether receiving the vaccine injections compared to placebo injections has a significant effect on reducing the number of new HIV infections. Originally, the study was designed to answer questions about whether the vaccine regimen can lower viral load among those who do become HIV-infected, and whether the vaccine regimen continues to be safe.”

Volunteers will not know whether they took the placebo or vaccine until after the study is complete.

—  Kevin Thomas

UT Southwestern marks HIV Vaccine Awareness Day

DAVID TAFFET | Staff Writer
taffet@dallasvoice.com

UT Southwestern’s Dr. Mamta Jain will be at ilume on May 18 to give a presentation on the necessity for an HIV vaccine.

Jain is heading a clinical trial of a vaccine that may help researchers understand how the immune system may prevent HIV. They are trying to understand why some people who are HIV-positive develop AIDS while others do not.

The study began last September but participants for the trial are still needed.

Jain said that participants cannot contract HIV from the vaccine.

“The vaccine is composed of man-made proteins that are found in HIV, not the HIV virus itself,” Jain said. “The vaccine cannot cause infection.”

Participants will receive three shots of either the vaccine or a placebo plus a booster shot in the first six months. Then they will return every three months for an HIV test, interview and risk-reduction counseling.

The study runs for three years.

Investigators are looking for gay men or transgender women who have sex with men who are between the ages of 18 and 5o and are HIV-negative. Testing to qualify would be done at UT Southwestern.

Jain will speak in the Great Room and Champagne Lounge at ilume, 4123 Cedar Springs Road on May 18 at 5-7 p.m. Free.

—  John Wright

UTSW seeks volunteers for HIV vaccine trial

Researchers at UT Southwestern Medical Center announced on Friday, Sept. 10, that they are looking for people at high risk of contracting HIV to participate in a three-year, nationwide clinical trial intended to determine whether a combination of two potential HIV vaccines will stimulate an immune response against the virus.

Dr. Mamta Jain, assistant professor of internal medicine at UT Southwestern, will be principal investigator for the study locally. She said the trial is designed to determine whether the new combo-vaccine will reduce the HIV viral load of people who subsequently become infected with HIV, preventing the onset of AIDS. She said that the combo-vaccine is composed of man-made proteins found in HIV, not the virus itself, and stressed that participants could not contract HIV from the vaccine. She also said the combo vaccine is designed to produce T-cells and antibody responses against HIV, and that it has proven safe in animals and hundreds of human volunteers during previous clinical trials.

The trial, known as the HVTN 505 study, will include 1,350 volunteers nationally who will be assigned randomly to receive either the combo vaccine or a placebo. Researchers with the study locally are looking for 40-50 volunteers to participate through UT Southwestern. The next closest site where the trial is being conducted is the Alabama Vaccine Research Clinic in Birmingham, about 650 miles from Dallas.

Investigators are looking for healthy, HIV-negative men between 18 and 45 who have sex with men, and transgender women who have sex with men. Participants will receive three shots of the combo vaccine or a placebo, plus a booster shot, within the first six months. They will then be asked to return every three months over the next three years for an HIV test, an interview and risk reduction counseling.

The study, funded by the HIV Vaccine Trials Network, “may help us better understand why some people develop AIDS and others don’t,” Jain said. “If you could prevent people from getting sick with AIDS, that’s a tremendous accomplishment.”

For more information about the clinical trial, call 214-590-0610 or 214-590-0603, or go online to HopeTakesAction.org. Go online to UTSouthwestern.org/InfectiousDiseases for more information about UT Southwestern’s clinical services for infectious diseases.

—  admin