HIV VACCINE TRIAL HALTED
Hundreds of Atlanta gay men volunteered for failed vaccine.
Nearly 200 metro Atlanta gay men participated in the national HIV vaccine trial named HVTN-505, known locally as Life Forward, before it was stopped last month after an oversight committee saw in preliminary results that people were being infected despite being vaccinated.
For Dr. Mark Mulligan, principal investigator of the Life Forward vaccine trial at Emory’s Hope Clinic, the news came as a huge disappointment.
“I was like, ‘Oh, wow.’ I felt a sort of shock and disbelief and disappointment. And there was some emotion,” he said.
Mulligan was notified in an email April 23 and given roughly 48 hours to call the participants before the news was released to the public. He was on rotation at Emory Hospital, visiting patients, some of whom were HIV positive. It was difficult, he said, seeing these patients who were coping with the disease and knowing a once-promising vaccine was proven ineffective.
The first priority was notifying all of the Hope Clinic’s volunteers.
“We called every one of them. We owed that to them,” Mulligan said.
Human trials began in 2009. The trial was being conducted in 19 cities, including Atlanta, and had more than 2,500 volunteers. All participants had to be HIV negative, sexually active and circumcised.
John Jeffrey, one of the Atlanta participants, had been enrolled in the study for one year and three months. When he received a call from the Hope Clinic, he was disappointed like others.
“I felt encouraged to be part of this program … and while a part of me is still disappointed, I feel good that researchers learned other things by the data collected,” Jeffrey said. “I want more of these studies out there and keep this at the forefront.”
71 HIV INFECTIONS OCCURED
The HIV vaccine trial was funded with $77 million from the National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health. In March, the trial had just finished enrolling the necessary 2,504 men who have sex with men and transgender people who have sex with men. Just weeks later the trial was called off.
On April 22, members of the oversight committee examined information gathered from 1,250 volunteers who received the vaccine and 1,244 volunteers who received the placebo. All had been in the trial at least 28 weeks. What they found was discouraging.
“Overall in the study from the day of enrollment through the month 24 study visit, a total of 41 cases of HIV infection occurred in the volunteers who received the investigational vaccine regimen and 30 cases of HIV infection occurred among the placebo vaccine recipients,” according to NIAID.
This vaccine was designed to impact the immune system so that it could fight off the virus and/or reduce the viral load of someone with HIV.
Three early shots within the first eight weeks were injected into volunteers and were intended to “prime the immune system.” Sixteen weeks later, volunteers were injected with a booster shot that delivered genetic material that made molecules produced by HIV — by doing so, researchers hoped for an immune response against the virus. The vaccine did not cause HIV infections.
‘IT GAVE US THE TRUTH’
The vaccine had shown protection in monkeys and there was hope it would work in humans, Mulligan said. And, like past attempts, it didn’t work.
“We don’t know how to protect humans,” he said.
“But the trial did what it was supposed to do. It gave us the truth,” he added. “It said this is not good enough. We have to do better.”
Currently, all the volunteers are now finding out if they received the placebo or the vaccine. All will be followed for five years, Mulli- gan explained. Those who received the placebo are eligible to participate in future HIV vaccine trials.
And there are many future HIV vaccine trials in the works. The Hope Clinic is currently enrolling in an early phase of a HIV vaccine trial named HVTN 092. So far, two people are enrolled.
An additional HIV vaccine study should open up this summer, Mulligan added, and other HIV vaccine trials are in planning and development. The Hope Clinic also has several ongoing and planned clinical trials of vaccines and treatments for influenza, HPV, TB, smallpox and anthrax.
While disappointed, Mulligan said as a scientist this comes as part of the job and it just means more work needs to be done.
“This is not a dead end. I’ve always put forward that when a door closes … some windows are going to open to something better. We are going to learn a lot,” he said.
“And in a way, we are going to be more successful. We are not giving up. We will continue until we have a vaccine.”
Above: Dr. Mark Mulligan, principal investigator of the HVTN505 vaccine trial, locally named Life Forward, said he was very disappointed to learn the vaccine was not effective, but said he and others would continue to work to find a way to stop HIV. (Photo by Emory University) Right: The Hope Clinic of Emory University advertised widely seeking volunteers for the Life Forward HIV vaccine trial. The trial began in 2009 but was discontinued last month after preliminary results showed the vaccine was not stopping HIV infections.