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The last time I wrote about one herpes vaccine - in that case Rational Vaccines' (RVx) Theravax, which claims to have performed well but only in one very pilot study in one foreign country, with no published data - I noted that future studies would be done in Mexico. (See: Herpes Vaccine Heads South ... Of The Border?", November 13, 2006.

The pilot study consisted of under 20 patients, and they published no data or methodology, but the company claims the results were encouraging. They also said they are planning more trials, but they would be held outside to the US to circumvent the FDA—an agency that Dr....

Since Genocea first reported data on GEN-003 (which would make it the first successful herpes vaccine ever) earlier this year, there has been massive interest in development.

This past September, a new player entered the field—Rational Vaccines (Rvx), which was founded by immunologist Dr. William Halford. RVx's Theravax claimed to have dramatically reduced genital outbreaks in 20 patients. Shortly thereafter, I interviewed Dr. Halford, to try and get additional information on Theravax.

You can find a table that compares (obviously apples and...

I have been paying close attention to the rapid developments in the race toward the world's first genital herpes vaccine. Since we first wrote about Genocea's GEN-003 efficacy in infected people this past March, hundreds of thousands of people have been following the vaccine's progress on this site alone.

This past September, I wrote about a small biotech, Rational Vaccines (RVx), which was co-founded by immunologist Dr. William Halford, an Associate Professor of the Southern Illinois University School of Medicine. To-date, Rvx had only conducted a very small (20 person) pilot study in St. Kitts, and claimed that the company's Theravax HSV-2 vaccine yielded results that...

Once again, the news is bad for the millions of people who are suffering from herpes simplex virus type 2 (HSV-2), much the same as I reported in September 2017, when Genocea's experimental herpes vaccine GEN-001 was dropped after Phase II clinical trials.

Today, less than a month after I interviewed Larry R. Smith, Ph.D., Vical’s Senior Vice President of Research about the prospects for VCL-HB01, the company's experimental therapeutic herpes vaccine, Vical announced that in randomized controlled Phase II clinical trials VCL-HB01 was ineffective in reducing outbreaks in people who were infected with HSV-2. This is just one more example of a vaccine failing in humans after...

NanoBio Corporation, a Michigan based biotech, just announced that they have received a $1.5 million grant (1) from the National Institute of Allergy and Infectious Diseases (NIAID) to run Phase II studies on its vaccine candidate for prevention (2) of herpes simplex virus-2 (HSV-2) infection (3). The company developed a nanoemulsion oil-in-water (NE) technology (4)— a mixture of very small beads of oil and water—to help deliver vaccines both intranasally and intramuscularly.

During pre-clinical studies, which were conducted by researchers at the Cincinnati Children's Hospital Medical Center, a nasallly administered version of NanoBio's NE vaccine has been studied in guinea pigs—a model that is known to be...

Since New, Promising Herpes Vaccine: Interview With Dr. William Halford was posted on October 17 many people have asked for more specific information about Theravax. The availability of the vaccine in the US (and in other countries) is a hot topic as well as Rational Vaccines' strategy of running a pilot study outside of the US.

Dr. Halford was kind enough to take the time to address these questions by making the following statement.

I do not believe that I said anything about making Rational Vaccines' Theravax HSV-2 vaccine available in the United States any time soon. This is certainly not where the clinical trial of this live HSV-2 vaccine was...

The story of Rational Vaccines' pursuit of a therapeutic vaccine for genital herpes may go down as one of the strangest and most controversial chapters in the history of drug or vaccine development. Dr. Bill Halford, formerly an Associate Professor at the Southern Illinois University School of Medicine, and virology and immunology expert, knew he was dying from nasal cancer which he had battled for years, but kept working in his lab until shortly before his death in July 2017. (You can read my interview with Dr. Halford here.) But it wasn't Halford's illness or endurance that makes this story so unusual; it was how the vaccine trials were conducted.

The story of Dr. Halford's ...

I have written much about herpes vaccines, especially Genocea's GEN-003 and Rational Vaccines' Theravax (1,2). Although we are still years from having an approved herpes vaccine, this does not mean that nothing is happening.

Based on positive results from Phase II trials (Genocea presented its results at a poster session at IDWeek 2016, in New Orleans last October ), the company is preparing for Phase III trials in the US in 4Q 2017. The company says that enrollment is already complete.

Rational is taking a very different route. The company, founded by Dr. Bill...

A paper in the Journal of Infectious Disease provides clinical data for Genocea's genital herpes vaccine GEN-003. The good news is that infected patients did respond to the vaccine. The not-so-good news is that the response was not as impressive as patients would hope. Here is a summary:

In Phase Ia/II trials (1), a total of 134 participants who were infected with HSV-2 were given a total of three injections of 003 three weeks apart. Three different doses of the vaccine were given, and the enrollees received genital swabs for four weeks before administration of the vaccine, and four more weeks after they got the last injection.

Summary of the results:

  • The vaccine was safe
  • The rate of viral shedding (2) for...

Earlier this year, I wrote about GEN-003, the world's first effective genital herpes vaccine (1). Since that time, our readers have expressed considerable interest in the clinical progression of this vaccine. So, as your "one-stop herpes resource supercenter" (probably not something you'd want inscribed on your gravestone), we have been following this vaccine and other developments in the field.

This week, there are some preliminary, but nonetheless very interesting developments; this time with a different vaccine (two, actually). Rational Vaccines (RVx), a biotechnology startup founded in 2015, focuses on vaccines for both genital and oral herpes...