St. Kitts island government probes unregulated herpes vaccine trial

A U.S. vaccine company sidestepped the FDA to test an experimental herpes shot on a Caribbean island, and now the island's government is investigating.

Following a rush of news coverage into an unregulated human trial of a herpes vaccine in St. Kitts, the island’s government is launching a probe. Now, the CEO of the company involved says his team will follow FDA rules, as it one day hopes to market the experimental shot in the United States.

The trial in St. Kitts made national headlines last week after Kaiser Health News dug into a study that’s already wrapped up but was never monitored by an institutional review board or the United States’ FDA, as is standard in medical research. As the news service pointed out, American patients traveled to the Caribbean island in order to receive the experimental treatment, potentially exposing themselves to unknown risks.

As criticism mounts against the investigators, the St. Kitts government is launching a probe, according to a press press release (PDF). Authorities there said “categorically that neither the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on this project.”

“By extension, none of these agencies has approved such a venture,” the statement continued. “As a result, an active investigation has commenced into this project.

Rational Vaccines licensed two patents related to the project from Southern Illinois University, according to Kaiser Health News. The company’s late co-founder William Halford was also an SIU professor. Halford died of cancer in June, according to the publication. SIU told the publication that Halford wasn’t doing the testing as part of his role at the institution.

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The team distributed the results from the trial last year, touting the vaccine candidate as a “new opportunity to solve the world’s herpes problem.” The results have not been published in a peer-reviewed journal, KHN pointed out.

Speaking with CNBC last week, Rational Vaccines co-founder and CEO Agustin Fernandez said he felt the need to “defend” his friend and partner. As they look to eventually reach the U.S. market, Fernandez said his company realizes the importance of FDA interaction. The helmsman is a Hollywood movie producer who doesn’t have a background in pharmaceuticals or science, according to the publication.

In an email to FiercePharma, Fernandez said "FDA strategy has always been part of our plan."

According to CDC data, more than 1 in 6 people aged 14 to 49 have genital herpes. Aside from the controversial trial, Genocea is progressing with its genital herpes vaccine candidate, GEN-003, which has completed midstage testing.