Herpes Vaccine Lawsuit Alleges Human Trials Unauthorized

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Three people recently brought suit against a herpes vaccine maker asserting that they received injections of an unapproved, experimental herpes vaccine causing them injuries. The plaintiffs, one woman from Colorado, a man from Texas, and a man who is a citizen of the United Kingdom filed a complaint in Illinois against Rational Vaccines, Inc. (RVX), a corporation located in Springfield Illinois.

The plaintiffs’ complaint sets forth an intriguing series of events occurring that violated international law and ignored the United States federal regulations with respect to the manufacture and control of investigational biological drugs for clinical use and human research subjects. In the complaint, the plaintiffs assert that William Halford, now deceased, was a founding member of RVX and was its chief scientific officer. In his capacity as an agent for RVX, Halford developed an experimental herpes vaccine he called Theravax from a live-attenuated Herpes-2 virus. The complaint asserts that the owners for the patent of the vaccine and rights to any profits from its sale were to be shared by Halford, RVX, and Southern Illinois University (SIU).

RVX purportedly represented that any of its human subject research would be conducted in full compliance with Institutional Review Board (IRB) and Federal Drug Administration (FDA) regulations. However, in the Fall of 2013, neither the FDA nor any IRB approved Halford’s untested and purely experimental vaccine when he personally administered the vaccine to a total of eight human subjects. The first plaintiff was vaccinated on September 21, 2013, at a hotel in Springfield, Illinois near Halford’s SIU lab.

Subsequently, in the Spring of 2016, the two other plaintiffs in the suit were injected with the vaccine by Halford on the Caribbean Island of St. Kitts where he purportedly had begun a second Phase One clinical trial of the vaccine. All three of the plaintiffs assert that they suffered severe adverse effects from the vaccine, some of which may be permanent. Upon learning of the unlawful clinical trial conducted on their island, the government of St. Kitts issued a statement emphasizing that SIU never approached their Ministry of Health or any of its officials about the project and that the clinical trials conducted there were completely unapproved. The statement also advised that an investigation had been launched by its Ministry of Health into the matter.

The lawsuit further sets forth that the plaintiffs became aware of RVX’s failure to conduct human subject research in compliance with the most basic ethical requirements after reading articles published by Marisa Taylor, a senior correspondent and investigative journalist for Kaiser Health News, a nonprofit health care news service. The herpes vaccine lawsuit quotes Jonathan Zenilman, Chief of Johns Hopkins Bayview Medical Center’s Infectious Disease Division with regard to RVX’s failure to comply with the safety regulations governing human subject research, “There’s a reason why researches rely on these protections. People can die.”

The various counts of the herpes vaccine lawsuit against RVX allege negligence, lack of informed consent, battery, and strict products liability. Each negligence count by the three plaintiffs assert that they incurred serious, debilitating, and excruciating personal injuries as a result of receiving the vaccine.

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