As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks.
The lead U.S. researcher, William Halford, openly acknowledged he was flouting Food and Drug Administration regulations in the consent forms they signed. He would be injecting them with a live, though weakened, herpes virus without U.S. safety oversight.
Still, many of them felt upbeat when they arrived on St. Kitts and Nevis in the spring of 2016. They had struggled for years with debilitating, painful herpes. Halford, the creator of the vaccine, sounded confident.
Maybe they could be cured.
"It felt like paradise," one of the participants recalled. "Or therapy combined with vacation."
A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks.
But they can't turn to Halford, a Southern Illinois University professor. He died of cancer in June.
They also can't rely on his university, which shares in the vaccine's patent but says it was unaware of the trial until after it was over. Because the FDA didn't monitor the research, it can't provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.
At a time when the Trump administration is pushing to speed drug development, the saga of the St. Kitts trial underscores the troubling risks of ambitious researchers making their own rules without conventional oversight.
"This is exactly the problem with the way the trial was conducted," said Jonathan Zenilman, an expert on sexually transmitted diseases at Johns Hopkins Bayview Medical Center in Baltimore. "These people are supposed to have rights as human subjects, but now there's nowhere for them to go. We may never know if this vaccine worked, didn't work or, even worse, harmed anyone."
Rational Vaccines, the U.S. company co-founded by Halford, still hopes to market the vaccine. It touted success online and to other researchers, prompting millions of dollars of recent investment, including from a company run by Peter Thiel, a backer of President Donald Trump.
Thiel, a PayPal co-founder who has excoriated the FDA as too bureaucratic, declined to answer questions about his investment, which occurred after the trial had ended.
Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of Halford.
The participants agreed to speak on condition of anonymity because they don't want to be known as having herpes. Most also said they feared retaliation from Halford's company but hoped by speaking out some of their concerns might be addressed.
Their accounts, along with documents, a video and emails obtained by KHN from the offshore trial, pointed to what experts said were serious irregularities:
_ Halford did not rely on an institutional review board, or an "IRB," which monitors the safety of research trials.
_ The company has said it doesn't know where Halford manufactured the vaccine, so it isn't known whether he followed U.S. government guidelines when transporting it.
_ Halford offered booster shots of the unapproved vaccine inside the United States. FDA regulations prohibit such injections.
"The FDA goes after these types of violations," said Holly Fernandez Lynch, a lawyer and assistant professor who specializes in medical ethics at the University of Pennsylvania's Perelman School of Medicine. "(Researchers) can be prosecuted."
SIU, however, did little to discourage Halford. The university, which has a financial interest in the patent, said it learned of "the concerns" only after his death. In August, after KHN asked about the trial, the medical school's IRB launched an investigation into whether Halford violated U.S. regulations or university rules.
In a statement to KHN, Rational Vaccines acknowledged that Halford "discussed a myriad of concerns ... including the potential need for booster shots."
"Unfortunately, Dr. Halford is no longer with us to address all the ways in which he may have investigated his concerns," stated the company. It added, "We nevertheless wholeheartedly intend to continue his line of investigation in a clinical setting to international good clinical practice standards."
