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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...

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...

An initially promising vaccine against herpes (HSV-1 and HSV-2) has failed in a large clinical trial, the results of which were just published in The New England Journal of Medicine. Researchers, led by a specialist in infectious diseases at St. Louis University in Missouri, are especially disappointed, given that two earlier but smaller trials for this new vaccine had found it effective.

The latest double-blind clinical trial randomly assigned 8,323 women, aged 18 to 30, who had no antibodies to HSV-1 or HSV-2, to receive either the herpes vaccine or a...

Good news in the world of virology.

For the first time, there is a promising vaccine to treat Herpes Simplex Virus type 2 (HSV-2), commonly known as genital herpes. HSV-2 is an infection that infects 500 million people worldwide, and 24 million in the United States, second in prevalence only to HPV among sexually transmitted viruses in the U.S. (The far more common herpes, which causes cold sores, is HSV-1.)

The vaccine, which is called GEN-003 is currently in Phase II trials (1), where it is doing rather well. More on this later.

For being such a common infection, there are big gaps in public knowledge about herpes, so here’s a quick primer:

  • Herpes never...

Sometimes drugs behave very well. They do what they are supposed to so, and do it well, maybe even without side effects (1). We are fortunate to have one of these that works against a very common infection—herpes simplex virus (HSV). 

There are two versions of the virus. HSV-1 is the type that causes cold sores, and HSV-2, which causes genital herpes (2). The two viral types are similar enough that they both respond well to the same drug—acyclovir (3).  The way that acyclovir works is a textbook example of an antiviral drug in action—shutting down an essential step that brings viral replication to a halt. The essential step that is shut down is the prevention of the formation of a phosphate ester bond—a key step in the...

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....

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 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...

In March, I reported on stage II results of the first ever herpes vaccine and its effectiveness in people who were infected with herpes. Data from trials of Genocea Biosciences' GEN-003 showed a modest, but real, effect in reducing symptoms and shedding (1) in people who were infected with HSV-2 (genital herpes).

Last month, I reported on Rational Vaccines' Theravax, which claimed to have significant advantages over 003; although, it is important to keep in mind that their conclusion was based on a tiny pilot study, not a clinical trial, and it was done in a foreign country to...

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...

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...