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The testing of a possible two-in-one HIV vaccine—a drug its manufacturer hopes would be used to both prevent and treat infections—has resulted in a dispute between Cook County Board President Todd Stroger and board and foundation members of the Ruth M. Rothstein CORE Center, Cook County’s South Side HIV/AIDS and infectious diseases clinic. Stroger, who initiated the testing proposal, is eager for trials to begin. CORE Center officials, however, have refused to go forward, citing concerns for patients and finances.

New collaboration
The CORE Center, founded by the Cook County Bureau of Health Services and Rush University Medical Center is the largest outpatient infectious disease clinic in the Midwest. The CORE Foundation is a non-profit that promotes and supports CORE Center’s work, in addition to its ownership responsibilities.

According to Stroger spokesperson Eugene Mullins, Stroger had last year supposedly become very interested in HIV vaccine research. Impressed by work at Atlanta-based GeoVax Labs, Inc., Stroger approached the company about bringing an HIV vaccine trial to Cook County, in particular the CORE Center. Mullins said Stroger first brought GeoVax to Chicago to discuss a possible collaboration in January.

On June 15, Stroger and GeoVax signed an agreement to discuss a potential collaboration between the Cook County board president and board of commissioners, the Cook County Health and Hospital Systems board and the CORE Foundation. If approved, GeoVax would start conducting a clinical HIV/AIDS therapeutic vaccine trial at CORE Center as early as this fall. The agreement included a potential future opportunity to conduct Phase 2a of its preventative vaccine trials at CORE Center, as well.

But by June 24, CORE Foundation had turned down the agreement.

Two-in-one vaccine
Scientists have been researching HIV vaccine candidates since 1987. Ideally, a successful HIV vaccine would prevent infection and serve as a more effective therapy than current HIV medications for HIV-positive people. GeoVax scientists, as well as scientists at Emory University, the CDC and the U.S. National Institutes of Health (NIH), have been working on the development of such a two-in-one vaccine candidate for years.

GeoVax’s preclinical study of the therapeutic vaccine among infected primates was successful. If the Phase 1 therapeutic human trial is successful, it could advance to Phase 2a or beyond, and include sites in Chicago. A medication or vaccine must pass several phases of testing before it can receive FDA approval to distribute. Phase 1 trials test for safety and effectiveness. Most trials don’t progress beyond Phase 1.

GeoVax would also like to conduct future preventative HIV vaccine trials through the CORE Center, starting as early as the winter.

GeoVax recently began a Phase 2a trial of its vaccine’s preventative application, conducted in 13 sites, through the HIV Vaccine Trials Network (HVTN), the largest worldwide clinical trials program. The GeoVax vaccine is one of only five HIV/AIDS vaccine candidates to progress to Phase 2 or beyond human trials conducted by HVTN, which is sponsored by NIH.

Medical reasons
But CORE Foundation says it doesn’t want the trials at CORE Center, largely citing medical reasons. On June 24, the CORE Foundation wrote a letter to Cook County Health and Hospitals System CEO William Foley that read, “After reviewing the scientific basis of therapeutic and preventative HIV vaccines—including discussions with the federally-funded HIV Vaccine Trials Network (HVTN), the federal National Institutes of Health (NIH) and internal experts...the medical/scientific recommendation is not to proceed at the Ruth M. Rothstein CORE Center with further discussion to evaluate the existing GeoVax vaccines.” 

CORE Foundation does not believe the therapeutic vaccine trial is appropriate, given its patient population.

“Based on medical and scientific recommendations we received, the Foundation decided not to accept the proposal,” said CORE Foundation board of directors president and Cook County Commissioner John Daley.

“It’s something our doctors looked at, and the main concern was GeoVax’s therapeutic trial,” said Cook County Health and Hospitals System spokesman Lucio Guerrero. “Our concern was that during the trial, patients would be taken off their (HIV) drugs while put on the therapeutic vaccine.” 

Reviewing the data
CORE Center Chief Operating Officer Dr. Robert Weinstein told CFP said that he and others at CORE Center spoke with the HVTN, several virologists, as well as other experts around the country from NIH, CDC and other groups, to reach this decision. CORE Center’s trained virologist, Dr. Dave Barker, also reviewed GeoVax’s data on their vaccines.

“They all said the same thing,” Weinstein said. “That the company is absolutely trustworthy and rock-solid. But the problem was with the therapeutic vaccine.”

According to Weinstein, there is no example to date of a therapeutic vaccine that has been successful, so that was the first reason for CORE Foundation to be cautious. Weinstein said GeoVax wanted newly infected individuals who were stable and on meds for the therapeutic trial, which concerned CORE Foundation. According to GeoVax spokeswoman Nikki Snodgrass, GeoVax management is unable to discuss details of protocol until the trial is approved by the FDA.

“We found the therapuetic trial…was not appropriate for our patient population,” Weinstein said, adding that it is difficult enough for CORE Center clients to take their HIV medications.

Guerrero added, “Folks I talked to at the CORE Center said it’s hard enough to get clients to take their drugs as it is,” and that they didn’t feel comfortable with the proposal.

Weinstein said that given CORE’s patient population, it is also very difficult to find someone who is newly infected. While they have been trying to do outreach to get people to come in for more regular testing and screenings, “In our population, people don’t usually come to us until they are ill.”

There are many patient populations, Weinstein said, where this therapuetic vaccine trial would make sense, but not at CORE Center.

Safety concerns
According to the NIH-funded AIDS Clinical Trials Group (ACTG), it is typical during therapeutic vaccine and medication trials for researchers to not allow certain unapproved treatments during the trial. Researchers have to be able to study the effectiveness and safety of a vaccine or drug candidate among participants. According to ACTG, during such trials, participants are fully informed of potential harms or side effects. The federal government imposes strict mandatory safeguards during such trials to protect volunteers’ safety.

During GeoVax’s trials on the vaccine’s treatment use among non-human subjects, primates were infected with HIV, placed on drugs, vaccinated and then taken off their drugs to determine whether the vaccine could control the infection. According to a GeoVax fact sheet on the company’s Web site, the therapeutic vaccine trial would utilize recently infected people who started drug therapy during the first year of infection.

Previous failure
Weinstein added that the recent failure of a promising HIV vaccine was another reason for the board’s cautiousness. In 2007, a large international HIV vaccine trial known as the STEP study, which was conducted by HVTN and pharmaceutical company Merck & Co., Inc., was discontinued because it failed to lower the risk of acquiring HIV. Some participants, in fact, were more likely to become infected, and the vaccine did not reduce the viral load among those who became HIV-positive during the trial.

But University of Chicago HIV vaccine researcher Richard Novak told CFP that GeoVax “looks like a promising product” that “doesn’t run the same types of risks” as vaccines that have failed in the past.

The ultimate authority
CORE Foundation is not the final decision maker in this case. The Cook County Health and Hospitals System is the ultimate authority. Hospitals System chair Warren Baits could, if he wished, force CORE Foundation and the Hospitals System board to accept the proposal. Yet Baits, according to Mullins, has usually listened to his board in the past.

During a June 26 Cook County Health and Hospitals System board of directors meeting, Foley recommended that the Health and Hospitals System board also not move forward with the proposal, citing a June 24 CORE Foundation board meeting, where the proposal was discussed at length with experts. He also submitted CORE Foundation’s letter stating their position.

Vetting
Mullins said that Stroger doesn’t believe CORE Foundation took enough time to reach their decision, and questions how many experts they were able to speak to before the June 24 letter to Foley, turning down the offer.

“That is only six business days between…receiving the agreement and writing the letter denying it,” Mullins said.

But Weinstein said that is not the case. Although they took “about two weeks” to research and discuss the issue, “We vetted this,” he said, adding that Foundation members knew people they could contact immediately to discuss the vaccine proposal.

CORE Foundation had no reason not to put a lot of work into looking into the proposal, according to Weinstein. When GeoVax first approached them, “We were excited,” he said, noting that those at CORE Center “love good ideas.”

“The vaccine for HIV would be the Holy Grail,” Weinstein said. “We know that. …But this is an expert’s expert issue. We talked to the most knowledgeable people on the planet. I think we did our homework.”

Money
In addition to medical and scientific reasons, money factored into CORE Foundation’s decision as well, although the official letter to Foley denying the proposal did not include this reason. CORE Foundation was concerned that GeoVax would require them to raise the funds for the vaccine trials, according to Guerrero, who added that Cook County Health and Hospitals System and CORE found this portion of the proposal “bizarre.”

While the proposal does indicate that CORE Foundation and the county would be responsible for obtaining funds, Mullins said, “Their concern over raising money isn’t legitimate.”

“They didn’t need or want the Foundation’s money,” Mullins added. “Not a syringe, nothing. They just wanted their patients.”

Snodgrass said that GeoVax cannot yet discuss any details about any possible financial arrangements with CORE Foundation.

Mullins added that, in the worst case scenario, if CORE Foundation had to find funding, “All CORE Foundation does with taxpayer money is raise money for infectious diseases, so why wouldn’t they try?”

According to Snodgrass, something else appears to be going on that is holding up bringing GeoVax to the CORE Center. The process “has kind of been moving a little bit slower than we initially anticipated,” Snodgrass told CFP.

“I don’t think it’s like people don’t think it’s important or anything,” Snodgrass added. “It’s just a bureaucratic issue.”

Where to go?
Regardless of the reasons, Stroger’s camp said that they will continue to fight to hold the vaccine trials in Cook County. But while his people promise Stroger won’t give up, talks with the other parties indicate that they believe this issue is dead.

Guerrero said, “Everybody is on the same page right now,” and that the “Cook County Health and Hospitals System agrees with CORE Foundation not to move forward with the proposal.”

Mullins said that if CORE Foundation passes this opportunity, GeoVax will approach someone else. “It will happen,” Mullins said. “It might not happen here, but it will happen.” In the meantime, he said Stroger isn’t going to stop fighting to keep GeoVax in Cook County.

“He has a responsibility for the health and welfare of the citizens of Cook County,” Mullins said, adding that Stroger hopes CORE Foundation will reconsider, but in the meantime, is considering other locations in order to keep the human vaccine trials in Cook County.

“There’s nothing on President Stroger’s agenda to deny this from coming to Cook County,” he added.