The Rogue Herpes Vaccine Trial involving 20 United States and British citizens was carried out in a private home on St. Kitts.
According to Marisa Taylor of Kaiser Health, the 20 herpes sufferers who flew to St. Kitts and received the injection in a house in St. Kitts and not at a medical clinic.
The lengthy article headlined : “A Dying Doctor, Peter Thiel, and a Rogue Herpes Vaccine Trial Gone Wrong” is reported by hundreds of media houses around the world,
Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of the leader researcher William Halford.
The participants agreed to speak on the 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 that 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.
The lead U.S. researcher, William Halford, organized two groups of 10 participants and instructed them on drawing their own blood for the trial, according to a video filmed in a medical lab.
He proceeded with the trial from April to August 2016, giving participants three shots over three months.
Once in St. Kitts, many of them quickly bonded with one another and Halford. Even though they ranged in age from their 20s to 40s and came from different regions, they had the disease in common. They commiserated about how herpes had wreaked havoc on their lives.
“It was a relief to meet people who understood what we were talking about,” the Southerner said.
But other participants now say they noticed some troubling signs.
Halford, whose gaunt frame made his cancer apparent by then, at times appeared disoriented.
Fernández, a constant presence, was introduced to them by name and made some of them uncomfortable when they socialized over drinks and dinner.
Some patients became anxious about their participation soon after receiving the vaccine.
One, a web developer in his 20s, felt ill after receiving just one dose.
“I experienced tiredness and ringing in my ears,” said the web developer, who reported the feelings along with “disequilibrium and slurred speech” continue to this day.
He said he decided not to return to St. Kitts for follow-up shots after Halford dismissed his symptoms as arising from a common cold.
Another participant, a Colorado woman in her 40s, said she told Halford she experienced flu-like aches and pains and tingling and numbness soon after the second shot. The symptoms were followed by an “excruciating” 30-day outbreak of herpes.
“I have new symptoms every day,” that woman later wrote Halford in an email exchange provided to KHN. “This is terrifying.”
Halford initially dismissed her symptoms, speculating they were caused by a mosquito-borne virus, she said.
She returned for the third shot but had her doubts. Halford and Fernández met her at a café to talk about her concerns, she recalled.
“[Fernández] kept saying, ‘You signed the consent form. You knew the risks,’” said the Colorado woman, who said Halford then removed her from the trial.
Another participant, a Californian in his 30s, said he went through with all three shots despite feeling a “terrible pain in my stomach.”
Halford then told him he had noticed in his research of mice that another version of the virus entered the gut of the mice and killed them, the participant said.
“I then thought maybe this is dangerous,” said the Californian, whose pain went away but his outbreaks did not.
Warren, the nurse practitioner in Oregon, said two participants tracked her down as a herpes expert. She said that they described possible side effects from the vaccine.
Halford had told participants he would follow up on their reactions to the vaccine for a year, according to the consent form. But he stopped sending questionnaires to the two participants who said they had been dropped from the trial.
Warren said that even when researchers stop administering a vaccine because of possible side effects, known as adverse events, they have a duty to track the subjects’ reactions.
“There is no doubt that these were adverse events that should have been reported,” Warren said.
Rational Vaccines did not respond to questions about the complaints. In previous public statements, it acknowledged that one of the 20 participants was concerned about possible side effects.
Some participants also wonder where Halford made the vaccine and how he transported it to St. Kitts.
Halford told his business partner he had made it outside of the United States, without disclosing where.
After the trial ended, some participants began complaining that the vaccine hadn’t worked. Halford and Fernández offered booster shots, according to four participants.
One participant, a man in his 40s who was also from California, declined to get the booster. He said he decided to go back to antiviral drugs when his outbreaks returned.
The Southerner said he agreed to allow Halford to give him booster shots at an office in Springfield, Ill., where Halford worked.
“It was between me and him,” said the participant. “He was doing me a favor.”
“I don’t know if it was a different strain or what, but he gave me a set of double boosters at the same time, one in each leg,” recalled the Southerner, who said he didn’t have records of the injections. He said he received them as Halford continued to collect data for the trial.
Months later, he said, he returned a second time for another set of boosters.
Halford, meanwhile, tried to persuade a U.S. scientific journal to publish a lengthy manuscript detailing the results of both his experiments on himself and his offshore trial. Halford put the cover letter on SIU letterhead.
In December 2016, only months after the trial had ended, Halford’s paper was rejected by the journal.
“This manuscript is partly a vision, partly science, and partly wishful thinking …,” said one reviewer for the journal. “Neither safety nor efficacy has been demonstrated by the data presented.”
Halford asked his former doctoral adviser, Daniel Carr, to attend a Rational Vaccines advisory board meeting. Carr, a University of Oklahoma Health Services Center professor, said he and other invitees heard glowing reports about the trial.
Carr agreed in May to present the trial data at a conference of herpes experts in Colorado.
A published summary of the event listed Carr as a lead author, though he said he wasn’t involved in the research.
“I just did it to help him out,” said Carr, who asked for his university’s permission to be on Rational Vaccines’ advisory board and is waiting for word on federal funding to study another version of Halford’s vaccine. “I also presented it because I thought that the scientific community would find it interesting.”
Despite its patent agreement reached in 2015, SIU said it was in the dark about Halford’s offshore activities until October 2016 — months after the trial had ended.
Halford, meanwhile, promoted his work at events attended by university officials.
In October 2016, Halford was a keynote speaker at an SIU-sponsored technology and innovation event to discuss his vaccine work.
Then, in April 2017, Halford and Rational Vaccines held a press conference to trumpet an investment pledge by Thiel’s company, according to materials handed out at the event. University officials, including SIU’s medical school dean, were invited speakers.
The university’s IRB is continuing its investigation, which includes scrutinizing whether Halford used university resources.
“If there are areas of concern, SIU will report those findings promptly to Department of Health and Human Services,” said SIU spokeswoman Karen Carlson. “We will also communicate our findings with the scientific community and the public.”
FDA spokeswoman Lauren Smith Dyer declined to comment on the trial except to say the FDA does not have jurisdiction over offshore trials that don’t seek agency approval.
Dyer, however, added that the export from the United States of an unapproved vaccine for research use and the injection of it on U.S. soil would be within the agency’s jurisdiction.
Even so, some participants don’t regret taking part in the trial.
“When you feel like a disease has ruined your life, you become desperate,” said the Southerner, who believes the boosters have lessened his outbreaks. “Some people contemplate suicide. You’re willing to do almost anything.”
Other participants still hope for some sort of accountability.
“I feel like without a doubt that my symptoms were vaccine-related,” said the Colorado woman. “I feel like it triggered something that I’ll have for the rest of my life.”
No matter what, experts said, the university has a responsibility to conduct an in-depth investigation. So far, the university has not reached out to participants who spoke to KHN.
“This researcher went rogue,” said Fernandez Lynch, the lawyer who specializes in medical ethics. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again.”
KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation and its coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.