Offshore human testing of herpes vaccine stokes debate over U.S. safety rules

August 28, 2017

Offshore human testing of herpes vaccine stokes debate over U.S. safety rules

Kaiser Health News

Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.

The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

But IHPI member, Kayte Spector-Bagdady, who leads the U-M Medical School’s Research Ethics Service, said the St. Kitts trial could be seen as a violation of SIU’s commitment to the Department of Health and Human Services.

SIU voluntarily agreed to follow U.S. safety requirements and set up an IRB for all research involving human subjects, according to records. Many universities make such a commitment to HHS, even if the experiments are abroad and don’t rely on federal grants.