Theravax / Profavax (Rational Vaccines)
Also known as: Theravax HSV-2, Profavax, Halford live-attenuated HSV
discontinued Rational Vaccines (William Halford)
Last updated:
| Developer | Rational Vaccines (William Halford) |
|---|---|
| Platform | live-attenuated |
| HSV target | both |
| Approach | both |
| Phase | discontinued |
| Status | CAUTIONARY / DISCREDITED — not a legitimate candidate. Tested in an unlicensed, unregistered offshore trial in 2016 without ethical (IRB) or FDA oversight. It prompted an FDA criminal investigation and university findings of serious regulatory noncompliance. The program is defunct. |
| Trials |
This is a documented cautionary case, not a live vaccine candidate. Theravax (and its preventive counterpart Profavax) was a live-attenuated herpes vaccine promoted by Rational Vaccines and researcher William Halford. It was given to about 20 people in 2016 in an offshore trial on St. Kitts that had no institutional review board approval and no FDA oversight — later the subject of an FDA criminal investigation and university findings of serious noncompliance. No credible efficacy evidence exists, and the program is defunct. It is listed here so readers can recognize why it is not a legitimate option.
This entry is documented cautionary history, not a live candidate. It is included so readers can recognize a discredited program, not because it is a viable vaccine. Nothing here should be read as a treatment option.
What it was
Theravax was a live-attenuated herpes vaccine — a weakened whole virus — promoted by the company Rational Vaccines and its co-founder, Southern Illinois University researcher William Halford. A preventive version was called Profavax. The vaccines were aimed at HSV-1 and HSV-2, both to reduce recurrences in people already infected and, in the Profavax form, to prevent infection.
Why it is discredited
In 2016, Theravax was given to roughly 20 American participants in a trial conducted on the Caribbean island of St. Kitts. That trial was carried out:
- without institutional review board (IRB) approval — the independent ethics review meant to protect trial participants;
- without U.S. Food and Drug Administration oversight; and
- reportedly, with some U.S.-based dosing near the researcher’s university before the offshore work.
The episode drew an FDA criminal investigation, condemnation from bioethicists, and a university finding of “serious noncompliance with regulatory requirements.” William Halford died of cancer in June 2017. No credible, peer-reviewed efficacy data ever came from this work, and the program is defunct.
Because the trial bypassed the safeguards that make clinical evidence trustworthy, its claims cannot be treated as evidence of safety or effectiveness. This history is a large part of why herpes-vaccine information needs careful, sourced reporting — the vacuum of an approved vaccine has repeatedly been filled by unproven and unsafe offerings. See our methodology for how we decide what counts as a credible source.