HIV Vaccine Trial Struggles to Enroll Volunteers
Tuesday, November 23, 2010
By: Euna Lhee, HealthyState.org

November 23, 2010 | WMFE - Last month, a trial for a new HIV vaccine started up in Orlando. The National Institutes of Health and a Seattle-based research organization have been recruiting volunteers nationwide for over a year, but they haven't found enough candidates. That's why they've expanded their search to Florida. One problem is the enrollment criteria are so stringent that many people don't qualify.

Study recruiter Keith Barsky talks to potential volunteers at a health fair near downtown Orlando.

Volunteers must meet 11 requirements before signing up for the HIV vaccine trial. They must either be “men having sex with men” or transgender females. They must have been sexually active in the last 6 months and also be HIV negative, circumcised and between the ages of 18 and 50.

"That’s been one of the biggest challenges is finding people who are actually eligible to be in the study,” said Keith Barsky, a study recruiter at the Orlando Immunology Center.

Orlando Immunology is the only site conducting the trial in Florida. Barsky is trying to recruit volunteers for the study at a health fair near downtown Orlando. On the table in front of him are yo-yos, mints and condoms with the slogan “Stand Up for Love.”

Erick Alvarez of Orlando comes by and asks what the study is all about.

"So what do you do? Do you inject them with HIV afterwards and say, ‘Oops, sorry?’ Alvarez jokes.

The HIV vaccine is made from synthetic pieces of the virus and cannot cause an actual infection. However, the vaccine stimulates an immune response, which may cause the volunteer to show positive results in some HIV tests for life.

Barsky explains all this to Alvarez and hands him a card. As Alvarez walks away from the table, he said that he doesn’t think he will enroll in the study, since he’s wary of clinical trials in general.

"I don’t know. It’s a man-made like vaccine, and I don’t know,” Alvarez said. “You know, it’s the whole, ‘What is it? Who made it? Am I going to grow another eye? Another thumb?’”

But some people are more trusting of clinical trials, like local resident Don Loftis.

Loftis was the first volunteer to enroll in the HIV vaccine trial in Orlando. He’d heard about it on Facebook.

"Well, I think people should participate in all sorts of medical trials and studies - anything that they’re interested in, or if they have the time and ability to do so,” Loftis said. “Because without the testing, they can’t make the products.”

For him, that outweighs the side effects of the vaccine, like pain at the injection site, headache and fatigue. Loftis will continue going to the Orlando Immunology Center for the next three to five years for follow-ups. He says it’s a small price to pay for the advancement of science.

Research to develop an HIV vaccine has been going on since the 1980s. More than 20 clinical trials are taking place around the world right now, but this one is the farthest along. Dr. Edwin DeJesus of Orlando Immunology is optimistic an HIV vaccine will be widely available within his lifetime.

"I think 20 years appears to be doable with the amount of knowledge that we have today,” Dejesus said. “Ten years is pushing it. Anything shorter than 10 years is too optimistic.”

Back at the health fair, study recruiter Keith Barsky says the day hasn’t been too fruitful. But Orlando Immunology has already enrolled 14 people in the first six weeks. As time goes on, he hopes to find more candidates through social networking and gay dating sites.

"This is one of the things that’s necessary as a step to finding a preventative vaccine, so that we can finally put an end to the whole world AIDS epidemic,” Barsky said.

The vaccine trial hopes to enroll a total of 1,350 volunteers nationwide.