The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Sen. Chuck Grassley (D-Iowa), the chair of the Judiciary Committee, applauded the FDA’s action after he had called on the agency to look into the matter, citing Kaiser Health News’ investigation.

“We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye …” he said in a statement. “This research broke just about every rule in the book and put human subjects at extreme health risk.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations, , began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court , a corporate official may be prosecuted for a criminal misdemeanor offense under the even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A , for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

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SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments.

Alan Milstein, a New Jersey lawyer representing the three participants, said his clients believe they should receive compensation not only for their medical costs, but also “pain and suffering” and loss of “dignity.” Milstein said he is still exploring legal options against the university, which shared in the vaccine’s patent, set up a business account to collect donations for Halford’s research and promoted his work.

“My clients are anxious to ensure such unethical experimentation on human subjects are not repeated,” said Milstein, who specializes in such cases.

A spokesman for Rational Vaccines did not respond to a request for comment. Earlier, the company had said that it plans to continue testing the vaccine and hopes to eventually secure approval from the FDA, although it’s unclear how it could without oversight from the federal government.

Halford co-founded Rational Vaccines with Hollywood filmmaker Agustín Fernández III in 2015. The company has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign. Thiel has declined to comment on his investment.

Rational Vaccines has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim.

Another participant, Richard Mancuso, has publicly asserted the vaccine cured him of herpes.

The lawsuit comes as the university is still investigating what it now describes as Halford’s misconduct.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently. After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university. The investigation probing his research and the help he might have received by other SIU employees is ongoing.

The dean of SIU’s medical school, Jerry Kruse, has refused multiple requests by Kaiser Health News for an interview, but in a statement he said he and other university officials knew nothing about improper research methods. Sen.Chuck Grassley, an Iowa Republican who is known for pushing for accountability on such matters, demanded a response from HHS and the university about their handling of the controversy. HHS’ Office for Human Research Protections, which is supposed to monitor such violations, may not investigate the matter, HHS told Grassley.

“OHRP expects that SIU’s forthcoming report will provide sufficient information … to determine whether the office has jurisdiction,” Matthew Bassett, the HHS assistant secretary for legislation, wrote Grassley in a letter obtained by KHN.

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SIU’s ethics panel launched a “full” investigation Dec. 5 of the herpes vaccine experiments by university professor William Halford, according to a memo obtained by Kaiser Health News.

Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without routine safety oversight from the Food and Drug Administration or an institutional review board, according to ongoing reporting by KHN. Some of the participants say they are experiencing side effects.

The panel, known as the Misconduct in Science Committee, told SIU’s medical school dean that the inquiry should not only investigate the extent of Halford’s alleged wrongdoing, but also scrutinize “members of his research team,” according to the Dec. 5 memo obtained through a Freedom of Information Act request.

“The Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days,” SIU spokeswoman Karen Carlson told KHN in an emailed response. “However, the investigation could take longer.”

The panel’s inquiry marks the second one to be launched by SIU since Halford’s methods were detailed in a KHN report in 2017.

The Department of Health and Human Services asked the university to determine whether Halford’s activities violated the institution’s pledge to HHS. SIU, a state university, had pledged to follow human-subject safety protocols for all research, even if privately funded.

In October, SIU medical school’s institutional review board determined Halford’s activities were in “serious noncompliance” with university rules and U.S. regulations and recommended that the misconduct committee investigate, according to records obtained by KHN under open-records laws.

Now, the committee has taken up the case, putting more pressure on SIU’s medical school, which initially said it bore no responsibility for the experiments.

The committee, which is made up of five faculty members, holds hearings about such misconduct and can call witnesses before reaching a conclusion.

The university is required to have such a committee to assure the federal government that it will examine allegations of research misconduct, said , a professor of health law at SIU’s medical school in Springfield,Ill. The medical school receives about $ 9 million a year in federal research dollars.

“Part of the reason this committee exists is to keep the federal funding clean and flowing,” said Spielman, who specializes in bioethics. “Any university that does research, especially with human subjects, wants to be trusted by the federal government and the public.”

In SIU’s response to KHN’s open-records request, the university excised the names of the committee members.

Carlson said that after the committee’s investigation is complete “in conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation.”

“Currently, no herpes research is being conducted at SIU,” she said.

SIU had said Halford conducted his research on human subjects independently in the Caribbean in 2016 with a company he co-founded with a Hollywood filmmaker. Yet, SIU’s medical school shared in a patent on a prospective vaccine with Halford’s company, Rational Vaccines, and promoted Halford’s vaccine research on its website.

The university has not responded to questions about its role in earlier experiments on human experiments by Halford. According to emails obtained by KHN and an account by one of the participants in the herpes vaccine experiment, Halford injected patients with the vaccine in 2013 in Illinois hotel rooms.

Many of the email exchanges with the participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab, which ethics experts said could constitute an improper use of state funds.

It is unclear whether the committee will have access to Halford’s or his former colleagues’ emails for its inquiry. An SIU colleague who had worked with him on his research took a job with Rational Vaccines, according to his online profile. Edward Gershburg, a former SIU professor, describes himself as the company’s chief technology officer, . Gershburg, who is no longer with the university, could not be reached for comment, and the company did not respond to questions about him.

In the Dec. 5 memo obtained by KHN, the misconduct committee pointed out that Halford received federal funding for his research on animals from the National Institutes of Health. In such cases, universities are supposed to ensure that researchers don’t use federal funding for unauthorized research, ethics experts told KHN. SIU’s Carlson said Halford’s NIH funds stopped in 2012.

“It is unclear at this time whether that grant is affected by the alleged misconduct,” stated the memo, which was sent to the medical school dean, Jerry Kruse, who assumed that role on Jan. 1, 2016.

In a reference to Halford’s nasal cancer, which was diagnosed before the human-subject experiments, the committee added: “We can only speculate as to [Halford’s] motivation, which may have been related to his terminal illness.”

NIH declined comment and HHS did not respond to questions.

The pressure on the university has intensified with attention from Capitol Hill and a high-profile lawyer.

In letters sent out earlier this month, Iowa Sen. Chuck Grassley, the Republican chair of the Judiciary Committee, told the Trump administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

In a separate development, three participants injected with an unauthorized herpes vaccine by Halford are demanding compensation from SIU for alleged side effects from the vaccine.

The participants recently hired , a New Jersey lawyer who specializes in litigating research abuses. In late December, Milstein notified SIU that the participants hired him to pursue litigation. Milstein asked for a meeting to discuss the participants’ fears about the vaccine and possible side effects.

“They realize now they were used as guinea pigs in outrageously unethical experiments that defied and flouted the most basic requirements of human-subject research in this country,” Milstein said in an interview.

The participants, who have herpes, have requested anonymity to protect the privacy of their health.

Milstein sent a similar letter to Halford’s company, Rational Vaccines.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign.

SIU declined to comment, and the company did not respond to questions about Milstein’s letter.

While critics have accused Milstein of relying on overly aggressive tactics that obstruct legitimate research, he is widely known to pursue research misconduct cases, even those involving some of the nation’s most prominent research institutions.

Over the past decade, Milstein has represented plaintiffs alleging research abuses committed by drug companies and prestigious universities, including Stanford University and the University of Pennsylvania. The complaints often have led to confidential settlements.

Regardless of whether SIU can be found negligent in court, Spielman of SIU said she believed the university owed the participants an “institutional apology” for how the research was conducted.

“The university should acknowledge that there must have been some kind of breakdown in the system,” she said.

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In sent out Thursday, Iowa Sen. Chuck Grassley also told the administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

Southern Illinois University professor William Halford tested his experimental herpes vaccine on participants in the Caribbean and in U.S. hotel rooms without Food and Drug Administration or institutional review board oversight. After Halford died in June and Kaiser Health News raised questions about the research, the university concluded he was in “serious noncompliance with regulatory requirements and institutional policies and procedures.”

“[T]his entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff,” Grassley wrote in the letters that cited KHN’s ongoing reporting.

Grassley, the chair of the Judiciary Committee, is well-known for pushing U.S. agencies to account for what he describes as breakdowns or lapses in the federal bureaucracy — even when the GOP is in charge.

In this case, his letters to the Department of Health and Human Services and the Food and Drug Administration could put pressure on the Trump administration to take a more aggressive role in any investigation of Halford’s research. Grassley’s letter to SIU could also lead to the university implementing tougher reforms in the wake of the unauthorized research, which participants say occurred as early as 2013 and continued into 2017.

“The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed [Halford], has put individuals at extreme health risk,” Grassley wrote.

Grassley also sent his letter to the federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials.

OHRP could have jurisdiction in launching an independent investigation because the university had pledged to follow human-subject safety protocols for all research, even if it was funded privately.

But experts say that the federal government has become less aggressive about pursuing human-subject research violations over the years.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.” That number has steadily declined. In 2017, it issued one.

Further politicizing the matter, Halford’s company, Rational Vaccines, received millions of dollars for future research on the experimental vaccine from billionaire Peter Thiel, a President Donald Trump supporter and high-profile critic of the FDA.

Thiel has not commented on the matter, despite investing in Rational Vaccines after Halford’s offshore trial.

SIU, meanwhile, has previously said it had no role or responsibility for Halford’s work, which it said it didn’t know about until after it was completed.

Following a KHN report that Halford completed the 2016 trial in St. Kitts and Nevis with no independent safety oversight, HHS demanded the university account for the research. The FDA and OHRP, however, have not commented on their roles in the matter.

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Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.

But don’t expect the disclosures after Halford’s death in June to trigger significant institutional changes or government response, research experts say.

“A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they’re hurt in the trial,” said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. “These types of cases are really a black hole in terms of accountability.”

The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.

Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford’s. He recruited subjects through Facebook and in some cases didn’t require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford’s offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.

“This is experimentation in the 21st century: heavily embedded in social media and combined with a hostility to regulatory oversight,” said Arthur Caplan, director of the Division of Medical Ethics at New York University’s School of Medicine. “How is the government going to manage subjects, researchers and investors who don’t like regulations?”

SIU officials initially brushed off any questions about Halford’s methods, saying the university did not have responsibility for the offshore vaccinations of the 20 participants in the trial because he formed an independent company to conduct the trial in St. Kitts and Nevis.

SIU eventually launched an inquiry last August, more than a month after Kaiser Health News began asking questions about Halford’s methods. The investigation is ongoing, although a preliminary inquiry found Halford’s methods to be in “serious noncompliance” with university rules and U.S. regulations.

Experts say the university should contact all participants who were injected with the vaccine and offer help to those who are suffering from side effects. But they point out that the university has potential conflicts of interest when scrutinizing its role in Halford’s research. SIU shared in the vaccine patent with Halford’s company, and medical school administration officials touted his work when Rational Vaccines benefited from Thiel’s investment.

In ongoing reporting, KHN learned that Halford injected a group of people in two hotel rooms near his lab in Springfield, Ill., in 2013, three years before he began experiments offshore. According to emails and one of the participants, many email exchanges with participants were sent from Halford’s university email account. He used the university phone and referred to a graduate student as assisting in the experiment and using the lab.

One participant has told the FDA he believes he suffers from adverse effects from the vaccine.

Yet Rational Vaccines continues to assert the vaccine is safe and effective, even though Halford’s data from his human subject experiments have not been published in a reputable scientific journal. Since the controversy, the company has taken down its website.

“This researcher basically violated all of the regulatory requirements and ethical principles guiding human subject research,” said Michael Carome, a doctor who directs the health research group for the nonprofit advocacy group Public Citizen. “Unfortunately, it seems everyone is trying to distance themselves here to avoid legal liability and a public relations embarrassment.”

The FDA, which has declined to comment on this case, could have jurisdiction, but it rarely takes aggressive action on behalf of human subjects, experts said. The FDA has had limited contact with two participants who have filed complaints alleging side effects from the vaccine.

“The FDA is just not set up to handle this,” NYU’s Caplan said.

The federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials, could choose to conduct an independent investigation. The agency would have jurisdiction because the university had pledged to follow human subject safety protocols for all research, even if it was funded privately.

Experts, however, remain skeptical that OHRP, an agency in the Department of Health and Human Services, would assume a prominent role in investigating the case based on the agency’s track record.

OHRP asked the university for an explanation after KHN first reported that Halford didn’t ask for routine safety oversight from an institutional review board.

OHRP once took on human subject violations that occurred during non-federally funded research and in cases where the FDA asserted jurisdiction, Carome said.

Now, the agency often chooses to stay out of non-federally funded trials and defers to the FDA, he said.

As a result, its public response to allegations of research abuse has plummeted, experts said.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.”  That number has steadily declined. This year, it has issued one.

“A single letter in one year is extraordinary,” said Carome, who was the agency’s associate director for regulatory affairs from 2002 to 2010. “OHRP’s compliance oversight activities are moribund.”

“The end result is the federal watchdog for human subject protections is ineffective in its role in investigating complaints” and preventing violations, he said.

OHRP maintains it has been using other “more efficient” approaches. Rather than automatically opening a case and issuing a determination letter, the agency is “working more closely with complainants and institutions to address some of the concerns raised about human subject research,” said an HHS spokesperson, who declined to be named citing agency policy.

“But … in situations where something seriously wrong occurred, or subjects were harmed, OHRP does take action,” the spokesperson said.

OHRP hasn’t taken high-profile, aggressive action in years, said experts who pointed to the government’s suspension of federally funded research at Duke University and Johns Hopkins University more than a decade ago.

The federal government’s unresponsiveness in cases of privately funded research became more pronounced under the Obama administration, experts said.

In the waning days of the Obama administration, the federal government approved the first major overhaul of regulations surrounding human trials in 40 years. The resulting changes to federally funded trials included making consent forms more concise and clear.

, associate professor at Vanderbilt University’s Center for Medicine, Health and Society, said that in federally funded trials the measure “shifts the balance towards protecting research participants rather than protect[ing] institutions against liability.”

However, the rule does not address privately funded trials.

“If [the] organization and studies are privately funded, then they are not beholden to the law,” Stark said

As more universities began dropping their pledges to follow safety protocols for all research, it had already become difficult for the agency to assert jurisdiction. Meanwhile, OHRP’s compliance staff dwindled from six employees in 2008 to two in 2017. The lack of accountability for privately funded research is unlikely to change, experts say.

Stark called Halford’s research “a potential harbinger of the future of medical research given the increase in private funding and the unlikely prospect of updating the regulations again anytime soon.”

Compounding the problem, the United States is the only developed nation that does not guarantee medical care for those injured in clinical trials, experts said.

When participants claim injury, they often are told to file claims with their insurance companies, an impossible endeavor, said NYU’s Caplan.

“We still haven’t figured out how to compensate people who say they are injured in research,” he said. “In cases like these, in which subjects are claiming harm from a cuckoo experiment, the system is set up to punish the institution rather than give redress to the subject. Their only route then is to sue.”

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Last week, Kaiser Health News reported that Halford conducted an experiment in which he vaccinated patients in U.S. hotel rooms in 2013 without any safety oversight and in violation of U.S. laws, according to patients and emails they provided to KHN to support their allegations.

They told KHN those injections occurred three years before Halford tested a herpes vaccine he created on human subjects in a house in St. Kitts in 2016, again without routine safety oversight. Halford died of cancer at the end of June.

While the university has refused to respond to questions about the 2013 injections, an Oct. 16 memo to the federal government obtained by KHN under open-records law shows that SIU learned of such possible activity at the end of July. According to the memo, Rational Vaccines, the company that Halford co-founded, and another SIU professor disclosed that “human subjects research might have occurred prior to the … clinical trial in St. Kitts.”

SIU reported in the memo to the Department of Health and Human Services and the Food and Drug Administration that its institutional review board, or IRB, found Halford’s activities to be a “serious noncompliance” and said it recommended the university conduct a “confidential” investigation to determine if he committed any other misconduct.

“Dr. Halford willfully and intentionally engaged in human subjects research without the approval and oversight of the IRB, in violation of IRB policies and in violation of applicable law and regulation,” SIU wrote in the memo.

Previously, the university had said it was not responsible for Halford’s St. Kitts trial because he conducted it independently through Rational Vaccines.

Before releasing the memo to KHN, the university blacked out some of the details. It’s unclear whether the “serious noncompliance” involved the 2013 injections or some other unauthorized human subject research.

“This is a very serious matter for the university,” said Robert Klitzman, a doctor and director of the master’s program in bioethics at Columbia University in New York.

Klitzman said the (OHRP), the HHS division that oversees compliance with rules on human trials, could halt all of the university’s research as a result of the finding. The National Institutes of Health could also freeze its funding to SIU, he added, even though Halford’s research was not federally funded.

OHRP and the FDA said they have policies of not discussing potential or ongoing investigations. SIU did not respond to questions.

Several participants from both trials told KHN they have asked SIU for help. They said Tuesday that they felt the university should be informing them of its investigation into unauthorized experiments and its findings.

“Halford tested his vaccine on humans using SIU’s facilities and resources,” said one Colorado woman who has tried to talk to the university about her experience in the St. Kitts trial. “They [SIU] deny knowing anything about it. SIU hasn’t been very forthcoming.”

Klitzman said the university did have a responsibility to the participants who were injected with Halford’s vaccine. Two of them — including the Colorado woman — have filed so-called adverse event complaints with the FDA, saying that Halford’s vaccine may have caused side effects.

“Ethically, the university should contact the participants to let them know that some participants have developed adverse events,” he said.

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Southern Illinois University associate professor William Halford administered the shots himself at a Holiday Inn Express and a Crowne Plaza Hotel that were a 15-minute drive from the researcher’s SIU lab. Halford injected at least eight herpes patients on four separate occasions in the summer and fall of 2013 with a virus that he created, according to emails from seven participants and interviews with one participant.

The 2013 experiments raise further questions of misconduct by Halford, who pursued a herpes vaccine for years while working at Southern Illinois University, which claims to have been unaware of his unorthodox research practices.

Halford, who died this summer from cancer, ran a clinical trial out of a house on St. Kitts in 2016 to test the experimental vaccine and did not alert U.S. or St. Kitts and Nevis authorities.

Following a KHN report that Halford completed the 2016 trial with no independent safety oversight, the Department of Health and Human Services demanded the university account for the research.

SIU, in an initial response to U.S. authorities, said the university’s institutional review board found “serious noncompliance with regulatory requirements and institutional policies and procedures.”

SIU, like many universities receiving federal research funds, pledged to follow U.S. standards for all clinical trials.

In 2013, Halford, who was a microbiologist not a physician, noted a need for secrecy in one email to a participant, writing that it would be “suicide” if he became too public about how he was conducting his research.

Many email exchanges with participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab.

“Furtive unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there,” said Jonathan Zenilman, a doctor and an expert on sexually transmitted diseases at Johns Hopkins University. “Someone in the university had to know that this stuff was going on. If they didn’t, they should have.”

According to the emails between Halford and the patients and extensive interviews with the participant, Halford did not procure written informed consent as required by federal law when testing a live virus on humans. Medical researchers, such as Halford, may not inject patients without oversight by a physician or a nurse practitioner, Zenilman said.

SIU refused to comment on revelations about Halford’s 2013 experiments.

It has previously said it had no role or responsibility for Halford’s work in 2016 in the Caribbean. The university has maintained it didn’t know about the offshore trial because he pursued that through Rational Vaccines, a company the professor co-founded in 2015.

But criticism has been raised about the university’s ties to Halford’s commercial venture.

SIU, based in Springfield, Ill., shared in a patent on the prospective vaccine with Rational Vaccines, which was formed to market and research the product. The university promoted Halford’s vaccine research on its website. And when a company owned by Peter Thiel, a supporter of President Donald Trump’s, invested millions of dollars into the research this April, SIU publicly trumpeted Halford and Rational Vaccines.

The Food and Drug Administration, which oversees the safety of vaccine research in the U.S., declined to comment on the 2013 experiments. It previously declined comment on the 2016 trial.

Since Halford’s death in June, several participants who received the vaccine in 2013 and 2016 have told KHN they have informed the university about what they fear may be side effects from the vaccine.

One participant who says he received the injections in Illinois fears that the vaccine, which contains a live virus, may have given him a new and different type of herpes he did not have, a scenario that experts who reviewed his medical details for KHN said was possible.

In recent weeks, that participant from Texas and a woman from Colorado who took part in the St. Kitts trial have separately electronically reported to the FDA their possible side effects, also known as “adverse events.”

They said SIU and the FDA have not adequately addressed their inquiries.

“It makes me angry that Halford went ahead with the offshore trial anyway,” said the man from Texas who did not want to be publicly identified because of the sensitive nature of his disease. “I hope more people weren’t hurt.”

Rational Vaccines has vowed to proceed with the research. The company, founded by Halford and Hollywood filmmaker Agustín Fernández III, has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim. In a statement, Rational Vaccines said that Fernández was not involved with Halford’s work before the company was formed but that Fernández was aware of “individuals who experienced positive outcomes from the vaccine.”

“Their stories are what sparked Mr. [Fernández’] future involvement,” the company stated. It did not address specific questions from KHN about the 2013 injections.

A representative for billionaire PayPal co-founder Thiel did not respond to questions about his investment in the vaccine. Thiel and other backers share libertarian political views that are critical of the FDA’s regulations.

The 2013 emails and interview with a participant show Halford began unregulated human experiments while working as an associate professor in the medical school’s department of microbiology.

The Texas patient said he first learned of Halford’s work through a members-only Facebook account. According to the emails, one woman helped Halford recruit patients and organize injections. This woman identified herself to KHN in an email as a herpes patient who was injected with Halford’s vaccine. She claims she was cured as a result.

KHN attempted to contact the other participants who received injections in 2013. They either declined to comment or did not respond.

In the emails, Halford describes some of his methods, including that he was varying the doses — as well as the number of shots. He communicated regularly with participants using a familiar tone.

“Just wanted to pass along that I immunized someone with the higher dose of the HSV-2 vaccine on Monday, and I attach the photos of the injection site at 48 hours to give you and everyone else an idea of what to expect …” he wrote on Sept. 19, 2013. “This individual requested that I give him two immunizations to double the effect … one immunization per leg.”

“Everyone’s vaccines contained ~150 million infectious units of the HSV-2 vaccine strain …” Halford wrote four days later, on Sept. 23, saying the first injection of the group represented about a thirty- to fortyfold increase over what others had received in August 2013.

In the same email, Halford said he believed the experiments were important to demonstrating that his vaccine worked.

“Saturday Sept. 21 definitely represents a milestone in my career,” he wrote. “Don’t know how it will turn out, but I undoubtedly feel like this was a real test of the (a) safety / tolerability of the HSV-2 vaccine and (b) an opportunity to see if it has any therapeutic potential.

“I am indebted to all of you.”

Halford also refers to using his university’s resources in the emails.

“My lab currently consists of myself and 1 graduate student and anything I do with you guys or your blood is extra and on top of what I get paid to do …,” he wrote in a Nov. 3, 2013, email. “If my graduate student gets to it before I do, I will pass along the results.” Attempts by KHN to reach the graduate student, who was not named in the email, were unsuccessful.

When discussing the possible effects of the vaccine in emails dated Oct. 2, 2013, Halford openly speculated about possible results, calling his analysis “nothing more than an educated guess.”

“The proof is in the pudding … let’s see if your problems with outbreaks dial back or not.”

The participants treated Halford with deference and were eager to receive the injections, the emails show.

The Texas man said he did not know how the trial was financially supported, adding that Halford wouldn’t accept money from participants because, as he told them, “it would get him in more trouble if he was ever caught.”

But Halford told participants they could donate money to SIU for his research, the Texas man said. SIU has confirmed that it set up a business account for donations to Halford, but the university has refused to say how the money was used.

When Halford invited them for dinner and drinks at his house, they agreed.  “I’ll do whatever he wants,” the Dallas man wrote about the dinner.

In the emails, the participants, who ranged in age from their 20s to 50s, were enthusiastic about the potential for the vaccine and freedom from often excruciating chronic symptoms. “I do believe [it’s] safe,” the Texas man wrote Halford on Sept. 15.

But months later, on Feb. 24, 2014, he said, he was frightened by a reaction to the vaccine, after his second shot. “I got a large rash on my leg and it burned and swelled,” he wrote to Halford. “… then a blister popped up.”

The Texas man has HSV-1, which usually emerges in sores on the face. Halford’s vaccine was a weakened version of HSV-2, which is genital herpes, according to descriptions he uses in the emails. “I did not think the HSV-2 vaccine strain would be capable of reactivation, but perhaps I will have to reconsider that,” Halford wrote in response in an email.

Anna Wald, a leading herpes expert at the University of Washington, said Halford should have informed the Texas man before testing that he was vulnerable to having side effects because he had a different herpes virus type than the vaccine Halford prepared.

Wald said Halford’s research — without oversight — jeopardized the patients.

“We’re not allowed to do this to guinea pigs in this country let alone human subjects,” Wald said.

But Wald said she could understand the participants’ desire for a chance at a cure. “People underestimate how desperate people with genital HSV are,” she said. “This is what drives even the possibility of a study such as Halford’s.”

SIU continues to be under scrutiny. Jerry Kruse, the dean of SIU’s medical school, responded to the HHS inquiry into the 2016 trial on Oct. 6 and indicated that the university has more to discover.

In his letter, obtained by KHN under the Freedom of Information Act, the dean said “if deemed necessary, SIU will develop an effective corrective action plan.” Some of the letter is redacted.

Several participants from both trials told KHN they have asked SIU for help.

The Colorado woman from the 2016 trial who reported a possible side effect from the vaccine to the FDA said she found university officials “dismissive.”

One participant, a Californian in his 30s, said he wanted the university to continue the vaccine work with safety oversight while “taking responsibility” for any improprieties.

SIU did not adequately address his questions, and he said: “It was obvious they want nothing to do with us.”

This article first appeared on ºÚÁϳԹÏÍø News and is republished here under a .