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William Halford, associate professor, SIU School of Medicine. Photo: Jason Johnson, SIU School of Medicine

In February, a Southern Illinois University’s School of Medicine press release touted a “game changer” herpes vaccine made by one of its associate professors, a three-shot inoculation that had reduced symptoms in the infected – and may eventually prevent transmission of the disease.

Just six months later, the school has all but disavowed the work.

“SIU School of Medicine did not conduct the herpes vaccine clinical trial,” the statement, released on Monday.

What had changed?

For one, William Halford, the SIU professor responsible for developing the vaccine, passed away in June after a long battle with terminal cancer at the age of 48. But the process of testing the vaccine on human patients has also come under increasing scrutiny.

The 20 patients who were already herpes-positive traveled to the Federation of Saint Kitts and Nevis, a Caribbean nation not far from Puerto Rico for the “clinical trials.” The injected vaccine doses and observations were not overseen by the U.S. Food and Drug Administration or an institutional review board, according to the initial SIU news release.

Instead, the biotech company founded by Halford and wealthy investors conducted the offshore trials. The scientist and Augustin Fernandez III founded the biotech company Rational Vaccines to accelerate the process of approving Theravax, with help from the SIU Office of Technology Transfer, to conduct the trials abroad without the regulatory limitations of domestic human experimentation.

Halford said at the time that the FDA approval process of potentially decades – especially for the live-attenuated virus variety used in the vaccine – was too long.

A “common-sense approach” was best to advance the treatment, since an estimated million people per week are infected with the herpes virus, and million more continue to suffer.

“Many of those people will face a lifetime of neverending isolation and pain caused by a chronic herpes infection,” said Halford, at the time. “So, do we run a small trial using something that’s been proven safe on animals for the past 20 years or do we sit on the sidelines? On the sidelines, people suffer.”

The SIU release concluded: “Fortunately, the FDA is no longer the only sheriff in town.”

But just six months later, the school passed the credit for the trials squarely onto the company.

“Rational Vaccines conducted the trial, which was brought to SIU’s attention in October 2016 after it had concluded,” SIU said in this week’s statement.

The trials violate traditional ethical standards - and could adversely affect the perception of vaccines that take the traditional route to approval, said Arthur Caplan, the director of the Division of Medical Ethics at New York University Langone Medical Center, in a statement to Laboratory Equipment.

"This is an unethical attempt at an end-around of federal regulations governing testing vaccines," Caplan said. "There is so much vaccine skepticism out there that it is a stupid maneuver since only a gold-standard tested vaccine has any chance of gaining a market."

Rational Vaccines announced a partnership with Thiel Capital and Iron Bridge Capital Management to further fund development of the vaccine.

Kaiser Health News reported on the new financing – and the accelerated experiments process – the same day the school disavowed the trials.

Fernandez told KHN that Rational Vaccines would continue the offshore trials, regardless of Halford’s death or the FDA’s stance on the trials – though he added he was hoping that the federal agency would be more apt to look at the safety investigations now that the work was completed.

The FDA approvals process, which has been developed over decades, has been a target of investors and patient advocates, especially with the change of the federal administration. President Donald Trump called the multi-step process of safety and efficacy taking years “slow and burdensome” earlier this year. The president added that he intended to “slash the restraints” of the FDA and other government regulatory agencies.

A handful of other herpes simplex virus vaccines are in development – but are going through the traditional FDA approvals process, according to reports. One competitor is a company called Genocea, which just finished phase II trials, and is planning to proceed to phase III in coming months.

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