Give Rational Vaccines a moment to speak to Congress about the burden of Herpetic Disease
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Hello my Name is Rich Mancuso and I suffered greatly from a disease called herpes for over 20 years. That was until I met a man named Dr. Bill Halford, who created a vaccine to treat HSV. The clinical trial was performed overseas but now it is pertinent to have a trial here in the United States. Why is this important? Because over 100 million people suffer needlessly from this herpetic disease. The good news is there is a solution but because of regulatory funding needs and FDA red tape, it is almost impossible to begin a trial here in the United States. Please help by signing the petition.
Dr Bill Halford, Associate Professor in the Department of Medical Microbiology & Immunology at Southern Illinois University, has been studying the Herpes Simplex Virus for 24 years. He has had the opportunity to use newer technology to develop attenuated safe vaccines as well as newer diagnostic testing. Theravax, an attenuated vaccine for HSV-2 that can treat and possibly lower transmission rates of both types of Herpes Simplex Virus. HSV is the cause of cold sores and genital herpes, but also can cause herpetic neuralgia, herpes gladiatorum (mat pox), whitlow, ocular herpes, neonatal herpes, meningitis, and encephalitis. HSV is the number one cause of ocular herpes which also happens to be the number one cause of infectious disease blindness in developed countries. In rare cases the virus can kill newborns whose mothers had not been infected or were infected in the later stages of pregnancy. Even just a simple kiss from a loved one who doesn’t have a cold sore can transmit the disease to a child.
Rational Vaccines, Inc. has formed to advance Theravax and other products developed by Dr. Halford into clinical trials. However, constraints of FDA regulation and limited funding has hampered the efforts to complete such trials in the US as FDA approved clinical trials. In 2016 a small non-FDA approved clinical trial was conducted in St. Kitts on a few people from the US and UK who were already infected with the virus. These people were suffering severe chronic symptoms of herpetic disease. After receiving a series of Theravax, not only were there no significant adverse events, the participants have reported that the vaccine has improved their symptoms better than current available treatments. It is also important to note that 65% of the participants in phase 1 of the St Kitts trial, have gone into full remission. Further study of a much larger group will confirm the safety and efficacy findings from the first trial
Experts in the field of HSV have believed for many years that a vaccine for HSV-1 was possible but funding for HSV vaccine research has gone to HSV-2. The theory is that an immune response for HSV-2 would also work for HSV-1. Many years ago, there was fear that HSV caused cancer but it was proven later that HPV was the culprit. That's why live attenuated vaccines were the least likely to be developed for HSV even though live viral vaccines have worked for other pathogens like small pox in the past.
Current antibody testing for HSV has a D grade and was the tool used in the latest analysis of genital herpes statistics listed by the CDC. Although the CDC stands by that analysis, there is real proof among the experts in the field that those statistics are incorrect. There is evidence that the incidence of genital herpes caused by HSV-1 is higher than previously thought. A more accurate picture of this silent epidemic is needed to really understand the burden of this disease. Experts have estimated that up to a million people in the US believe they have genital herpes due to a false positive test. There are several million more who believe they are not infected when they are. That is unacceptable. Advancing Theravax in clinical trials can also be helpful to try and determine a better understanding of the disease burden as antibody testing taking place in these trials will be conducted with more accuracy than in previous trials.
Efficacy of the vaccine’s ability to reduce asymptomatic shedding (an infectious outbreak without symptoms) also needs to be determine. More recent studies of such shedding have revealed that asymptomatic shedding is the typical outbreak instead of the symptomatic outbreak seen in physicians and STD clinics. Asymptomatic shedding can take place on average 8-18 times per year.
Although most people don't suffer from this virus, it is now so common that that small percent who do suffer is now in the millions. Millions who suffer in silence because of the stigma. There is no statistic showing the number of suicides caused by a genital herpes diagnosis but it is known that some people do in fact commit suicide after being diagnosed.
The WHO has stated in the past year that HSV-2 needs to be tracked in countries at high risk for HIV transmissions because the experts have also known for 20 years that there is a link between genital herpes and HIV. Where ever you see high rates of HIV transmissions you also see high rates of HSV transmissions. More recent studies that included biopsies have determined that genital herpes attracts the immune cells that HIV infects.
This vaccine can be what is needed to prevent all transmissions of both HSV types, treat the current infections causing disease, and lowering the HIV transmission rates in high risk populations. While there are vaccines currently in clinical trials, those vaccines are using the same failed approaches that have taken place over the last 30 years. Although there may be an iteration of this approach that might work in the future, so far, the current vaccines being tested do not look to be affective enough. So, the burden of herpetic diseases continues. The US should be testing every developed vaccine possible.
Trials are now moving forward overseas but we are asking for trials to begin here. Hopefully with enough signatures, this gesture will show a desperate need for change and allow a clinical trial to begin in the U.S. It is obvious that a working vaccine can help millions of people who suffer. Let's help prove it.
Please sign and support the movement to allow members of Rational Vaccines a time slot to speak with congress and hopefully some time with the NIH and FDA to see what can be done to begin fast tracking clinical testing here in the USA.
Thank you for your support.
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