William Halford, PhD, a recently deceased medical researcher, injected at least eight patients with an experimental, live-virus vaccine in Illinois hotel rooms in 2013, three years before launching an unregulated herpes vaccine clinical trial in the Caribbean, according to an investigative report from Kaiser Health News.
Here are five things to know.
1. Dr. Halford administered the injections at two hotels located near Dr. Halford's lab at Southern Illinois University School of Medicine in Springfield, where he developed the vaccine. Seven patients corroborated this information via email and one participated in an interview with KHN. The herpes virus researcher did not procure written informed consent from the individuals before administering the experimental vaccine, as required by federal law, according to the sources, who also provided emails from Dr. Halford to KHN,
2. In 2016, Dr. Halford headed up a clinical trial for the experimental vaccine out of a house on St. Kitts without alerting the U.S. or island authorities. While it's not illegal to conduct such a trial, the Food and Drug Administration and many physicians believe the practice is not safe. A group of wealthy businessmen and the Springfield-based company Rational Vaccines backed the trial. The company shares a patent with SIU for the prospective vaccine.
3. Since Dr. Halford died of cancer in June, several individuals who received the vaccine in 2013 and 2016 told KHN they've informed SIU about potential side effects from the vaccine. One individual who received the vaccine in Illinois told KHN he fears the vaccine may have given him a new type of herpes he'd not had before. Two participants from the St. Kitts trial have reported adverse events to the university and the FDA, but told KHN neither organization has adequately addressed their inquiries.
4. After KHN reported on the 2016 clinical trial in June, HHS demanded the university account for the research. In its initial response to the department, the university's institutional review board said it identified "serious noncompliance with regulatory requirements and institutional policies and procedures." However, the university refused to comment on the 2013 incidents.
"Furtive unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there," Jonathan Zenilman, MD, a physician and an expert on sexually transmitted diseases at Johns Hopkins University in Baltimore, told KHN. "Someone in the university had to know that this stuff was going on. If they didn't, they should have."
5. Rational Vaccines, which was founded by Dr. Halford and Hollywood filmmaker Agustín Fernández III, plans to proceed with the research and considers the 2016 study successful, though it is unclear what evidence the company has to support the claim, according to KHN.
To read the full report from Kaiser Health News, click here.
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