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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...

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...

Make room, Genocea and Rational Vaccines. There may be a new Herpes kid on the block.

A new study describes a trivalent vaccine—containing different strains — called HSV-2 gC2/gD2/gE2. HSV-2 refers to the herpes strain that causes genital herpes (1), and gC2, gD2, and gE2 are glycoproteins—proteins that are bound to sugars—that have different functions. The gD2 protein helps block the entry of the virus into the cell, while gC2 and gE2 help the virus evade the immune system.

This means that the vaccine produces antibodies that target two different mechanisms that help HSV-2 cause infection. 

The degree of protection of the new vaccine, as well as...

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....

If you ever need a reminder about how difficult it is to discover new drugs or vaccines, here it is. Despite 100 years (!) of research we still don't have a vaccine for herpes simplex (1,2). 

There is now another failed herpes vaccines, but this time it's not bad news for genital herpes sufferers. Vical, a California-based biotech, announced that its vaccine for cytomegalovirus (CMV) doesn't work and will be dropped. But, what does this have to do with herpes?

Most people know very little about CMV (3). Although the virus, is not a problem for most of us, it can cause very serious infections for people with compromised immune systems, especially transplant patients. CMV has another name: Human herpesvirus...

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...

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 they have refused to show any results...

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...

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...

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...