The researcher who conducted a controversial 2016 herpes vaccine trial on the island of St. Kitts without federal safety oversight had secretly begun the trial in the US three years earlier—in hotel rooms not far from his academic lab. That’s according to a new investigation by Kaiser Health News.

That researcher, the late Dr. William Halford of Southern Illinois University, administered shots to at least eight people with herpes in 2013. Without any federal or institutional approval or oversight, he administered the shots himself in rooms at a Holiday Inn Express and a Crowne Plaza Hotel within a short drive from SIU. Halford, who passed away from cancer in June of this year, was a microbiologist, not a physician.

Several people who received the vaccine have since complained to the FDA and SIU, reporting potential side effects. Those include large, painful rashes and becoming infected with a strain of herpes different from their initial infection.

Halford’s actions represent a flagrant violation of laws governing human clinical trials. They will likely further ensnare SIU and Halford’s company, Rational Vaccines, in controversy.

Halford’s conduct has already drawn sharp criticism and rebuke following the August report of his unapproved trial on the Caribbean nation of St. Kitts and Nevis. Experts called the trial “patently unethical.” Scientists rejected data generated by the trial from publication. And authorities from St. Kitts opened an investigation into the trial, while US authorities from Health and Human Services sent an inquiry to SIU regarding Halford’s work.

But conservative investors critical of US regulations, including PayPal co-founder Peter Thiel, invested $7 million into Halford’s research based on the trial results. Those results were considered “partly wishful thinking” by scientists. But Halford painted the trial and the vaccine as a success, as did Agustín Fernández III, the co-founder of Rational Vaccines.

Adverse events

In addition to new concerns over Halford’s ethics and conduct, the latest investigation raises more alarms about the vaccine and the trial participants’ health.

One participant from Texas reported having a frightening reaction to the vaccine months after receiving it. “I got a large rash on my leg, and it burned and swelled... Then a blister popped up,” he wrote to Halford in an e-mail. The man had entered the trial with an infection of herpes simplex virus type I (HSV-1), which mainly causes cold sores. But the vaccine was based on HSV-2, which typically causes genital herpes. The participant now fears he has an HSV-2 infection as well.

Scientists who reviewed data from the St. Kitts trial called side effects of inflamed patches of skin “not acceptable.” They called Halford’s disregard of safety precautions as “reckless.”

Several participants, including the Texas man, said they complained to SIU about the trial, but they said that the university had been dismissive.

A spokesperson for SIU declined to answer Ars’ questions about the 2013 trial and the university's treatment of participants. The university is now facing questions from federal regulators over Halford’s research and the university’s oversight. SIU says that it was not responsible for ensuring that Halford’s 2016 St. Kitts trial followed appropriate regulations because Halford was working independently with his private company. If SIU is found to have violated federal regulations, it could jeopardize millions in federal research funding that it receives for other work.

The SIU spokesperson pointed to an online statement about the ongoing issue, which says in part:

The initial IRB [Institutional Review Board] investigation has determined that serious noncompliance with regulatory requirements and institutional policies and procedures occurred. The IRB investigation has closed, and the IRB has submitted its report to the Office for Human Research Protections and the Food and Drug Administration in accordance with the lRB's policies. As a result, an investigation under the Southern Illinois University policy on research misconduct has begun. That investigation is in process. Once that investigation is completed and evaluated, we will provide more information, including any steps deemed necessary to ensure that research at SIU is both safe and compliant with all regulations.

In e-mailed responses to Ars, Rational Vaccines said it couldn't comment on the 2013 testing and was unaware of side effects participants experienced from those tests. The responses explained that: