In the US, one out of six people ages 14 to 49 carries the herpes-simplex virus. African American women have the highest rate of herpes infection at 48 percent and are nearly twice as likely as men to be infected.
But now there may be a cure for this disease. Dr. William Halford is the founder of Rational Vaccines (RVx) formed in 2015. This biotechnology company is on the leading edge of herpes research. Dr. Halford invented the Theravax/HSV-2 vaccine. The company recently announced groundbreaking results from the Phase-1 clinical trial of the vaccine. If the drug makes it to the marketplace, it will help many people around the world. Dr. Halford stated that four billion people are infected with herpes simplex virus serotype 1 (HSV-1) and/or herpes simplex virus serotype 2 (HSV-2), and every week more than one million people are newly infected.
Dr. Halford spoke with rolling out about his vaccine:
Why is herpes at an epidemic level among millennials today?
This is nothing new it’s been going on thousands of years. What has happened is we have gotten better in our ability to recognize and diagnosis. The one in six figure you quoted is really people that are infected with the virus. The real figure is about one in ten who actually have symptoms and recognize they are infected with HSV. If you think back a hundred years we would not have the techniques to determine an infection that is asymptomatic. (when a person is showing no symptoms of an infection) Today we have better technology in that we can determine that 4 billion people on Earth are infected with HSV-1 or HSV-2.
What was your “genius” moment when you realized you could stop the spread of HSV on a new level?
Let me preface by saying that I am not a genius. The moment was about ten years ago when I was studying a mutant variation of herpes-simplex virus-1, called an ICP-Zero mutant. A part of my research was why this virus was so incapable of causing disease among animals. That’s really what I was categorizing , I wasn’t really thinking of a vaccine. I decided to take one group of animals and infect them with the real virus and found that they were completely resistant to infection. That was the ‘eureka moment’, this thing I have been studying for ten years actually turned out to be a vaccine.
Can you describe in simple terms what the Theravax vaccine is and what it does?
With the Theravax vaccine HSV-2, we are actually taking the Herpes-Simplex Virus-2 from nature; isolated from a patient. Then in a laboratory setting you manipulate the virus. A virus is just a big long piece of DNA. I manipulated the virus so that it contains added properties. Now it cannot spread very far when you inject an animal or a person, so it does not cause disease. It’s just a virus.
The Theravax shot is a lot of virus. Normally when people are having an outbreak, maybe there’s a thousand infected units of virus floating around their body at any point and time. A pretty low level for a virologist. The amount of virus in the shot is about 150 million units, that’s about 100k times greater. This presents the virus to the body in a way that it cannot possibly miss. Normally the virus is ‘flying under the radar’ of the immune system. We are giving the immune system a better look at what HSV-2 really is. For people who suffer with the disease their immune system has been tricked into not responding to the virus anymore. This is why the infection is not being controlled and they are having outbreaks. Some people in our trial were having outbreaks 12-40 times a year, so basically they had constant outbreaks. For me as an immunologist I ask ‘Well what’s going on here?’. What it means is that their immune system has checked out on the virus and let it run rampant. The shot presents an overwhelming amount of HSV-2 and also causes an inflammatory spot raised on the skin. Those two things trigger the immune system to respond. So we’re getting the immune system back in the game where it can control the infection. It does not remove the infection, we can’t get rid of the latent infection. It just gives the body better control of the infection.
What were the results among your clinical trial patients?
This was first and foremost a safety study. We basically asked 20 people when they received the vaccine was it ‘no big deal’ or ‘outrageously bad’. The answer was more or less at the ‘no big deal’ end of the spectrum. The way we are making are comparisons and claims are that ‘look something has really changed here’. The patient population we selected for this trial were persons with a really high level of the disease. Many of whom had more than forty or fifty days per year of herpes symptoms. That means that many had 3-12 days per month of herpes symptoms. Also they had the virus ranging from 3 to 25 years, so they had a long history with it. So we had a pretty good reference point for what the normal was when it came to their symptoms. We spent a lot of time pre-vaccination over a 4 month period asking them what their symptoms were like to get a better understanding of each person’s life with the virus. We then spent time together post-vaccination and asked the same questions. What we found on average was a three to three and half fold reduction in the early phases. As the later phases progressed we found that this had increased to a seven and eightfold reduction.
What are some of the symptoms of herpes infection?
That is a great question because it’s so much more complicated than doctors realize. With a woman, the typical symptoms would be around the labia, the outer lips of the vagina. A bump sort of like chicken-pox, would appear. This is not all over but it one area that may become a red raised area of skin. Some outbreaks last longer and will progress to a scab or open sore. The area of redness or soreness may last a day or up to 3 weeks. What many doctors don’t realize is the skin is just one indicator of the disease. The virus lies along the backbone . There is nervous tissue coming out of each side and that is where the latent virus resides. That is the source of the symptoms of I described. The virus travels down nerve fibers to get to the lips of the labia. Some people experience symptoms were they have intense burning or stabbing pains in their spine and groin area and describe a feeling like spiders under their skin. That’s because the nervous system where the virus lives are sensory nerve pods that signal the brain that something is happening. The virus causes the neurons to misfire and the brain interprets this as pain. In piratical terms, it is similar to the pain people experience when they have shingles, but herpes sufferers experience every day of their life.
When do you project this vaccine will be available?
As far as reaching the global market where a parent takes their child for and receives a live herpes vaccine so that they don’t get herpes, that’s probably 20-25 years off. But our company Rational Vaccines (RVx), is not waiting for that end goal of deployment. The goal is to expand the circle of people treated. Right now we have treated 20 people, the next goal is to treat another 200 people and that will be happening next year. Basically, that builds a scientific case and after we treat 200 our next goal is to treat 20,000 people. We hope this to occur sometime after 2018, We are still in the early phase of testing but we are quickly trying to proceed with sales of the vaccine outside the jurisdiction of the United States. There are about 100 million people living with a very high-level condition of the chronic disease I just described to you ;there really is no standard of medical care that addresses their problem. We’re basically trying to make it available today and if necessary there are logistical steps we can take to scale up at a later date.
Is it possible for people in the United States to sign up for future clinical trials of the vaccine?
Yes… Our website is setup to accept clinical trial applicants. The website is designed in such a way that people can express an interest in the product. That helps us both with recruiting people and allows current and future investors to realize that there is a real demand for the vaccine. Just go to Rational Vaccines.
In closing, what would you like to say to those who may be suffering from HSV infection now?
There is light at the end of the tunnel. If you step outside the science and look at a historical perspective, genital and oral herpes are absolutely preventable diseases. Not only can we eradicate herpes and protect future generations. We can actually dial back the disease in 100 million people that have been suffering in silence. The medical community is doing the best they can with their current tools. But the tools that Rational Vaccines (RVx) are about to offer are way better and will really improve the quality of life of a patient.
