A Springfield researcher last week reported “stunning reductions” in genital herpes symptoms during the first phase of an overseas clinical trial of his therapeutic herpes vaccine.

Though involving only 17 U.S. and British patients with herpes who received a series of three shots over a three-month period in a Caribbean island country, William Halford said he hopes to offer his Theravax vaccine to the general public next year in an as-yet-undetermined foreign country.

Halford, whose vaccine is the product of research at Springfield’s Southern Illinois University School of Medicine and is produced in his private company’s downtown laboratory, said he plans to publish full results of the phase 1 trial in a scientific journal in late 2017.

But Rational Vaccines, the company he co-founded last year, said in a news release that initial results of the trial, using a live but weakened form of the herpes virus, positions Halford’s Theravax vaccine as “one of the most effective therapeutic vaccines ever created” for people suffering from one of the world’s most common sexually transmitted infections.

Can't wait for FDA

In the United States, about one in seven people ages 14 to 49 — more than 23 million people — have genital herpes. As many as 3 million suffer herpes outbreaks four to 24 times per year.

Worldwide, more than 400 million people have genital herpes, with tens of millions living with chronic symptoms, including chronic pain, that often aren't alleviated with available medical treatments.

Halford’s phase 1 study, conducted in the Federation of Saint Kitts and Nevis — a two-island, sovereign nation about 200 miles southeast of Puerto Rico — met its primary goal of demonstrating “safety and tolerability” in genital herpes patients who had lived with chronic symptoms for one to 25 years, Halford said.

“This early phase trial revealed Theravax elicited stunning reductions in herpes symptoms among trial participants,” the Rational Vaccines release says. “Specifically, 17 of 17 participants who received the three-shot vaccine series indicated the live Theravax vaccine was more effective in reducing their genital herpes symptoms than antiviral drugs.”

The patients had taken antiviral drugs for years and decades before they took part in the clinical trial, Halford said.

On average, the participants reported a threefold reduction in their number of days with herpes symptoms, according to the release, which says a “functional cure” for herpes “may be on the horizon.”

This early phase study, which will conclude in June 2017, didn’t include a “placebo control group,” and the symptoms were self-reported rather than evaluated by a medical professional. It also lacked the number of patients required to thoroughly evaluate the treatment’s effectiveness.

Halford said he was well aware of these limitations. A phase 1 clinical trial that proves safety paves the way for phase 2 and 3 trials that measure effectiveness, he said.

The vaccine, which works by stimulating the immune system, holds too much promise for easing human suffering to be delayed by the traditional 20-year process required to bring a vaccine to market in the United States, Halford said. This process is overseen by the U.S. Food and Drug Administration.

Halford isn’t a physician but said the Hippocratic oath that doctors take to “do no harm” makes his next steps clear. Those steps, he said, are similar to those a doctor faces when paramedics carry a gunshot victim into a hospital emergency room.

“You should not sit there and confer with your colleagues and attorneys for 10 years while that person bleeds to death,” Halford said.

“The next step,” he said, “is to go anywhere in the world where they want a better herpes treatment option and start to develop it. For our company, what makes the most sense is to go to any sovereign nation in the world that is willing to offer the highest level of cooperation and bring potentially life-improving medicine to herpes sufferers ASAP."

'Attenuated' viruses

Halford, 48, said he would continue research overseas that eventually could lead to FDA approval of "vaccines within the United States with the potential to alleviate the chronic pain and debilitating symptoms from which far too many herpes sufferers can find no relief with the current standard of medical care offered in the USA."

In fact, going overseas could help Rational Vaccines bring a vaccine to market in the United States in fewer than 20 years, said Halford, an SIU associate professor of medical microbiology, immunology and cell biology.

Halford said he knows news of his Theravax clinical trial results may invite criticism from other scientists.

It’s unusual for an American scientist to go overseas to conduct clinical trials, Halford said, though he noted that the chickenpox vaccine was developed in Japan in 1974, then tested and used in Japan for decades before it was purchased by the pharmaceutical company Merck in the late 1980s. The chickenpox vaccine received FDA approval for use in Americans in the mid-1990s.

Moreover, there is continued resistance in the U.S. scientific community to the use of a live, “attenuated” viral vaccine even though the vaccines for chickenpox, measles, mumps, rubella, polio and yellow fever were developed decades ago with live, attenuated viruses.

Since the 1970s, genetic-engineering techniques became available that can create alternatives to vaccines with weakened viruses. American scientists now generally think that vaccines with “attenuated” viruses pose unnecessary risks of complications and disease for patients.

However, herpes vaccines created with a piece, or protein "subunit" from a virus have failed in decades of clinical trials.

Halford's company already has developed a vaccine to prevent genital herpes infection, Profavax, which Halford said is "100 times more effective than the herpes subunit vaccines" that have been tested in U.S. clinical trials over the past 30 years.

The next step, he said, is to test Profavax in a phase 1 clinical trial similar to the trial of Theravax. Profavax, he said, could be a boon to partners of people with genital herpes by eliminating their risk of being infected.

'Astounding' results

The scientists from SIU and elsewhere at the SIU Technology and Innovation Expo in Chicago on Oct. 13 gave Halford’s presentation of his herpes vaccine trial results a positive reception, according to Dr. Jerry Kruse, dean and provost of SIU School of Medicine.

“I hope this works. The initial results are astounding,” Kruse said.

Halford is “an outstanding scientist — a genius, actually,” Kruse added.

Kruse said Halford’s team, which includes Rational Vaccines employees Joshua Geltz and Ashley Mihalich, is “excellent.” SIU would like to see more of its scientists leverage their research discoveries and create local companies, Kruse said.

Dr. David Koelle, an infectious-disease specialist and herpes vaccine researcher at the University of Washington in Seattle, said the track record of live, attenuated vaccines is “good,” but he wouldn’t comment on Halford’s trial until all of the data are available.

Koelle said he respects Halford as a scientist, but the “bar for safety in vaccines is extremely high in the United States.”

“The evaluation of any vaccine or treatment must be done with the utmost care and oversight,” Koelle said. “It’s important that we balance safety in clinical trials without categorically rejecting promising treatments or vaccines.”

Herpes patients in the United States will be encouraged by news of Halford’s trial and won’t mind if a vaccine is developed overseas as long as it’s safe and effective in preventing or treating the infection, according to Fred Wyand, spokesman for the North Carolina-based American Sexual Health Association.

“This is something people have talked about for a long time,” he said. “People are clamoring for it.”

Global Industry Analysts Inc. have estimated that the global market for treatments to reduce the severity of chronic herpes symptoms will reach $4.8 billion annually by 2017.

The global market for Halford’s proposed preventive vaccine, Profavax, could be more than $10 billion per year, he said, because for every herpes sufferer, "there are 30 people who remain vulnerable to contracting genital herpes."

SIU owns the patent for the technology Halford developed and would evenly split any royalties with him. Halford, who teaches medical students, said he has no plans to leave SIU or Springfield.

“I can use Springfield as a base of operations and go anywhere,” he said.

Sad commentary?

Rational Vaccine’s chief executive officer Agustin Fernandez III said he isn’t worried about finding investors willing to help Rational Vaccines do research and serve patients in foreign countries.

The challenge, he said, is finding investors who share the company’s long-term vision of eradicating genital herpes. About $750,000 has been raised from investors to get the company to this point, Halford said.

Fernandez, 40, who said he lives in Los Angeles and New York, is a movie producer and director. He shared an Academy Award in 2014 as executive producer of the short documentary, “The Lady in Number 6,” and he directed the 2015 crime thriller, “Badge of Honor.”

Fernandez, who is one of the company’s investors, said he contacted Halford to become involved because of the impact of herpes on people in his life.

Fernandez said he has cut back on his film work to devote full time to Rational Vaccines. The fact that the vaccine is being developed overseas is a sad commentary on U.S. regulations, he said.

“The concerns of U.S. regulators don’t seem to be in line with patients’ needs,” he said. “The people who need the treatment don’t care where the treatment comes from.”

— Contact Dean Olsen: dean.olsen@sj-r.com, 788-1543, twitter.com/DeanOlsenSJR.