Petition to congress for awareness and HSV trial in the United States

[Rational Vaxxer]

 Please sign petition to help get this vaccine trial in the United States and gain positive support from NIH and Congress.  Brought to you by @Sweet7 @passionatepisces 

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 is an attenuated vaccine for HSV-2 that can possibly treat and 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 takes place on average 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 just might 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.
 
Please allow Dr. Halford a time slot to speak with congress and hopefully some time with the NIH and FDA to see what can be done to move forward with clinical testing in the USA.     

 

 

 

http://Petition to Congress for holding an HSV 1-2 vaccine trial in the United States https://www.petition2congress.com/22875/give-dr-bill-halford-moment-to-speak-to-congress-about-burden-h

Edited January 5, 2017 by Rational Vaxxer

[hopeful Rylee]

How many have to sign and do these honestly get taken seriously and work?

How many have to sign and do these honestly get taken seriously and work?

[passionatepisces]

Lol if everyone in the u.s. that had hsv signed it I think they would take notice  @hopefulrylee 

[Hansje]

When I click the link I'm brought back to this page. How can I sign? Is this a new petition or the same as yesterday?

Edited January 5, 2017 by Hansje

[OFMDH]

4 hours ago, hopeful Rylee said:

How many have to sign and do these honestly get taken seriously and work?

Consumer/AIDS groups in the past have already fundamentally changed the FDA. Eventually they made available drugs that would otherwise not have been available during testing and doubled the speed of the drug review process as they secured much more staff and retained the talent necessary from instituting application/user fees. 

For 2017 its slightly over $2 million to apply for a new drug requiring clinical data. Seriously someone should consider lobbying for a fee waiver application. 

How did they do this? Their best weapon was intimate knowledge of how the FDA worked and what they wanted changed; further this was prepackaged for the media to take notice and eventually did after a year or two.  

Right now the FDA is already in a 10 year safety trial of ACAM529 a replication deficient virus (2 open reading frames removed). But the FDA considers a live fully replicating HSV vaccine unsafe 1) risk of establishing latency/neurovirulence; 2) potential reversion to wild-type; 3) making people worse 4) and comments include concern whether one would turn an asymptomatic person symptomatic. 

Until these issues are addressed no amount of lobbying the FDA will change their concerns about safety regardless of how willing you are to taking it. One can get a plan together to answer all of this then bring Doctors, Patients, etc. to the NIH and request the funding to run the experiments/tests so that then RVx could eventually get a safety study going with the FDA. As for getting a message prepackaged for the media to get attention I don't know. 

 

 

Edited January 5, 2017 by OhFuckMyDickHurts

[Rational Vaxxer]

6 hours ago, hopeful Rylee said:

How many have to sign and do these honestly get taken seriously and work?

How many have to sign and do these honestly get taken seriously and work?

Thousands

5 hours ago, Hansje said:

When I click the link I'm brought back to this page. How can I sign? Is this a new petition or the same as yesterday?

 It's the same one you already signed

[Hansje]

ok thank you

[HopeComing]

hey guys I posted this on the reddit herpes subreddit and im going to try posting it on a few other subreddits to get more signatures coming. please make a reddit account and upvote this. 

 

 

[HopeComing]

Is there any way we can get a mod to post this on the front page or something?

[passionatepisces]

1 hour ago, HopeComing said:

hey guys I posted this on the reddit herpes subreddit and im going to try posting it on a few other subreddits to get more signatures coming. please make a reddit account and upvote this. 

 

 

your reddit post is working :] were at over 300 signatures now! hopefully more people will have faith in this product and advocate for themselves.