Rational Vaccines, a fledgling U.S.-based biotechnology company, has come under fire for its decision to conduct Clinical Trials for its genital herpes outside the United States and outside normal guidelines. The experimental vaccine, Theravax, is described by the U.S. company as the first in a line of herpes vaccines developed using live-attenuated herpes simplex viruses.
So-called live-attenuated vaccines such as Theravax use live viruses or other infectious agents that have been rendered harmless or significantly less virulent in the laboratory. As an example of a successful live-attenuated vaccine, Rational Vaccines cites VZV (varicella zoster virus) Oka, a vaccine that “has profoundly curbed the incidence of chickenpox over the past 20 years.”
Tests Conducted in Caribbean Nation
The clinical trials for Theravax were conducted on the two-island Caribbean nation of St. Kitts and Nevis. Rational Vaccines claims that it had secured permission from government officials to conduct such trials, but that claim is rejected by officials in St. Kitts and Nevis.
Ordinarily, clinical trials of an experimental vaccine proposed for use in the United States are monitored by the Food and Drug Administration through an institutional review board, or IRB. Such boards are set up to monitor and review all biomedical research that involves human subjects. According to the FDA, an IRB has the authority “to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights, safety, and welfare of human research subjects.”
Rational Vaccines Founded in 2015
Rational Vaccines, headquartered in Springfield, Illinois, was cofounded in 2015 by Cuban-American filmmaker Agustin Fernandez and William Halford. The latter, who died in June 2017, was an associate professor of microbiology and immunology at Southern Illinois University School of Medicine, and served as the company’s chief scientific officer until his death. Fernandez serves as the chief executive officer of Rational Vaccines.
When questions arose about the safety implications of the company’s offshore trials in St. Kitts and Nevis, Fernandez said that he had assurances from Halford that the professor had received permission from the island nation. However, government officials in St. Kitts and Nevis claimed they had not been notified of such clinical trials nor had they given approval for such testing.
Clinical Tests Can Be Conducted Abroad
To be clear, FDA regulations do not prohibit clinical testing outside the United States, but they do require that such tests be monitored or reviewed by an IRB or a comparable review group at the foreign testing location. An IRB or its equivalent in another country has the authority to shut down clinical research studies if it has reason to believe that the safety of study participants is being jeopardized.
The clinical trials in question were conducted in St. Kitts and Nevis between April and August 2016. The majority of the study’s participants were Americans and not citizens of St. Kitts and Nevis.
Fears of Infection Cited
Safety concerns about experimental trials with live viruses, according to an article at Salon.com, focus on the fear that such viruses could lead to infection if handled improperly or produce side effects in those already infected. In its response to some of the concerns voiced about the safety of the clinical trials conducted by Rational Vaccines, the company said there was little risk the participants would be harmed because they already had herpes.
Genital herpes is a sexually transmitted infection that is caused by one of two herpes viruses — herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2). Roughly 150 million Americans are infected with one or both of these viruses, which can cause few if any symptoms in some of those infected but can produce periodic outbreaks of painful sores in others. The virus can be spread through sexual contact or released through the skin of those who are infected.
Pall Cast Over Trials
In its official response to revelations that Rational Vaccines had conducted clinical trials of the vaccine in St. Kitts, the country’s Ministry of Health flatly denied that any official body had been petitioned for authorization to permit this study. “By extension, none of these agencies has approved such a venture.”
Concerned about the threat of infection with genital herpes or some other sexually transmitted disease, some women — and men as well — may lose their desire for sex, particularly in the absence of protection. If an effective vaccine can be developed to prevent infection with either of the herpes simplex viruses, this would certainly ease the worries of many.
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