Hun­dreds of At­lanta gay men vol­un­teered for failed vac­cine.

GA Voice - - Front Page - By DYANA BAGBY dbagby@the­

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.”


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.


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.

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