Theravax^HSV-2 Vaccine Trial: Initial Findings

siu-tech-expo

Rational Vaccines (RVx) just announced at the SIU Tech Expo the initial findings from the Theravax^HSV-2 Vaccine Trial that was conducted between March and August 2016.  Data collection and analysis will be ongoing for the next 8 months, so the results are far from finalized.

Although there is a great deal of science that remains to be done, changes so profound in a small Phase I Clinical Trial suggest the live Theravax^HSV-2 Vaccine may be game-changer in how doctors manage recurrent herpetic disease in the future.

The Press Release on this announcement may be found here:  https://www.firstwordpharma.com/node/1425206?tsid=1

A reporter from the American Council for Science and Health, Josh Bloom, wrote a short article on this press release based on an interview with me on October 17, 2016:  http://acsh.org/news/2016/10/17/new-promising-herpes-vaccine-interview-dr-william-halford-10313

Regarding the talk developed for the SIU Tech Expo, there are two sets of viewable items below.

The first set of items are what was presented at the SIU Tech Expo today, which very briefly summarize RVx’s technologies and the initial findings of a recent Phase I Clinical Trial of the Theravax^HSV-2 vaccine.


The second set of items were generated specifically for followers of this blog who have followed my research for months to years.  What is presented is a more informal and longer version of the SIU Tech Expo talk, which more fully discusses each of RVx’s three technologies that I would consider 21st century herpes solutions with the potential to radically improve the (1) diagnosis, (2) prevention, and (3) clinical management of genital herpes.  This longer version of the talk is broken up into five parts that address the following points.

  1.  Introduction
  2.  Better Herpes Diagnostic Tests                            >>             HSV ABVIC Test
  3.  Preventative HSV-2 Vaccines that work            >>             ProfavaxHSV-2 vaccine
  4.  Better relief from recurrent herpetic disease  >>             TheravaxHSV vaccine
  5.  Conclusions

Under each of these two sections, what is provided is:

  1.  A PDF of the slides presented in each talk.  Please note that anywhere within the slides that the text appears as blue font on a white background, this is a hyperlink that connects to the relevant reference material.  People should not take my word that what I say in these talks is actually true.  Rather, people should use these talks as a quick synopsis that pulls together all of the relevant references (dating back 40 years) that paints a picture of (1) why herpes remains an unsolved problem and (2) why RVx’s more-effective 21st century technologies will succeed where past approaches have failed.  Again, people, do not take my word for it.  Educate yourselves, so that we can start replacing misinformation with Accurate Information that will inform the world as to why herpes is an infinitely solvable problem.

2.   Video / audio (mp4) files that convey the actual content of each talk.

Finally, thanks to everyone who follows the blog for your personal and financial support.  Today is not a win for Bill Halford, or for RVx……it’s a win for herpes sufferers.  RVx could not have accomplished any of this without the day-in and day-out support I have received from herpes sufferers over the past 4 years.  So, thanks guys….you earned this!

–  Bill H.



1. SIU Tech Expo Talk (10-minute presentation that hits the high points)

PDF of SIU Tech Expo Slides (Short Version)

Watch the Audio/Video of Halford’s SIU Tech Expo Talk



2. LONGER / MORE COMPLETE VERSION OF SIU TECH EXPO TALK

PDF of Long Version of SIU Tech Expo Slides

Watch the Audio/Video of the Long Version of Halford’s SIU Tech Expo Talk in 5 Parts:

  1.  Introduction   (13:30)
  2.  Better Herpes Diagnostic Tests                            >>             HSV ABVIC Test             (11:57)
  3.  Preventative HSV-2 Vaccines that work            >>             ProfavaxHSV-2 vaccine (11:24)
  4.  Better relief from recurrent herpetic disease  >>             TheravaxHSV vaccine (36:00)
  5.  Conclusions    (0:42)

39 thoughts on “Theravax^HSV-2 Vaccine Trial: Initial Findings

  1. vmare says:

    I want to thank you for your hard work! The information provided it is very promising, I know the vaccine will make tons of people happy again, including me. Living with HSV 2 have changed my life completely, for good and bad! You are in my prayers!
    Is there a way to know more information about the clinical trial-phase 2? How can I participate?

    Like

  2. MissJ says:

    Hello Dr. Bill,
    I hope you are doing ok. I know you don’t answer every message, but I take a chance if ever you read mine. I will try to make it short: I have HSV2 and it never leaves me alone. I’ve been taking Valacyclovir since I was diagnosed 2 years ago and I still get OB every month (periods..) and feel often a burn or itch for some days without an OB too. I have not many days left during a month (even a year) with feeling good with my body and mind. I have no doctor in charge. I was left with only pills to help. No one around knows. The pain is real. Last year I wanted to end my life; had therapy, but this hole in my heart remains. Had so many pills to take. I feel so fragile. How can I know where and when there are trials? I live in Canada, close to Montreal in Quebec, near USA and I have a passport. What can I do? This thing takes all my energy away as well. Doing my job as a teacher gets very difficult.

    Thank you Dr. Bill for all your hard work. ❤

    Like

    • Mark says:

      Hi Halford,

      Do you speculate we will be able to live a life as if we were never infected after receiving your vaccine at its optimal dose?

      Like

      • Herpes Vaccine Research says:

        Hi Mark,

        If HSV-seronegative partners receive the preventative HSV-2 vaccine, then they should be immune to all diseases caused by HSV-2 and likely HSV-1 as well and should not have to worry about contracting HSV-1 or HSV-2. This is the correct way to look at this, and yes this is totally do-able. Persons already infected with HSV-1 or HSV-2 may benefit from the therapeutic HSV vaccine, but I think it would be an oversimplification to say it would be like they were never infected at all. Better is do-able; undoing all aspects of the infection in terms of completely reversing the risk of shedding infectious virus seems like a heavy lift to me. Despite 30 years of anti-herpes antiviral drugs, to date all we have achieved is a 2-fold reduction in HSV-2 shedding and this is just too small of a change to really move the needle on HSV transmission risks.

        With the preventative vaccine, you can think in relative absolutes….should reduce people’s risk of contracting herpes by >99%. With the therapeutic HSV-2 vaccine (based on a live-attenuated virus), I think there is a great deal of promise there based on the trial RVx recently ran, but it will take further research before we can commit to hard numbers in terms of the reduction in the relative levels of shedding of HSV-1 or HSV-2. I am optimistic this will be an improvement for most herpes sufferers, but it would be irresponsible to speculate beyond (overinterpret) what the current data set shows.

        I believe the therapeutic HSV vaccines can bring a great deal of relief to a lot of people, but it will require study and practical clinical experience on thousands of patients before we can define what a “great deal of relief” means and which subset of herpes sufferers reap the most benefit. My limited experience to date suggests that individuals who live with herpes-induced neuropathic pain may be big beneficiaries of the therapeutic HSV-2 vaccine, but I will feel more comfortable with that conclusion after we replicate it in another 100 patients who suffer with this condition.

        So, I am optimistic therapeutic HSV vaccines can help and I am certain that preventative HSV vaccines can stop the spread of all herpetic diseases. But, there remains a lot of science to do, and we need to ramp up the number of patients, doctors, and researchers involved in this research by several 100-fold before it will may to have a global impact.

        – Bill H.

        Like

  3. anonymous says:

    Great work! I know you can help us herpes sufferers. You are a gift from God. Continue doing great work and give hope to millions or billion of people worldwide. I am excited that these will be out in the market soon, like next year outside of US or available online.

    Like

  4. Sam says:

    I also read the interview with RollingOut, and you state that RVX will do another trial with 200 participants in 2017, and then another trial with 20,000 sometime after 2018…which is great.
    It seems like RVX intends on spending a couple more years in trials, am I wrong to assume that this vaccine is still 3+ years out from being publicly available the masses?

    Like

    • Herpes Vaccine Research says:

      Hi Sam,

      The typical timeline for a vaccine at RVx’s stage to deployment to the masses is 20 years. We are hoping to cut that in half, and start making it available to those who need it ASAP immediately. So, from our end, we are making the vaccine available to the masses in the latter half of the 2010s, but people will have to trial to those countries that offer the vaccine.

      – Bill H.

      Like

      • Mark says:

        Hello Halford,

        Can you elaborate on this a bit? Half of 20 is 10 years. Do you expect the vaccine to be available next year or two or in 2026?

        Like

      • Herpes Vaccine Research says:

        Hi Mark,

        This message is more for the group than you, so don’t take this personally. I can either spend my time answering 10,000 one-off questions, or I can just do my work and help the world eradicate herpes. I personally think the latter is a better use of my time. If someone wants to donate $10,000 to my research, then sure, I’ll take a phone call. Attorneys don’t work for free, nor do I. The blog is a vehicle to share information, which I do. However, I just don’t have time to answer every single person’s questions. Feel free to ask, and I will feel free to ignore and focus on what is important….solving the herpes problems. Happy to share updates, when I have time. Not answering every picayune question though.

        – Bill H.

        Like

      • Mark says:

        My apologies. Some of us just need hope to keep moving forward. This has devastated many of us and it would be a nice thought to know that a vaccine is just around the corner. I am hoping the vaccine is available within a year or two or the foreseeable future but time will tell I guess.

        Anyways, crush it!

        Like

    • su says:

      Hi doctor bill. Im so glad that i found your blog. And i am really sorry about to hear your health. I will pray for your health and job that you are doing.

      I have a really simple question which an answer would be yes or no. Is your vaccine that now developing is gonna work for hsv 1 too? Or its only for hsv 2? Or you dont know yet. I tried to find if someone asked the same question but i couldnt. It would be really nice to know the answer. In korea the number of herpes suffers started to increase since 2000. And we know about your work and looking forward to it! Thank you for your effort. Wish you success things you deserve!

      Like

    • Mark says:

      Hey Halford,

      Question;

      Lets say someone was on antiviral therapy for 6 months and after 6 months experinced reduced outbreaks and symtoms. Would having intercourse with someone with the hsv2 make it worse again? If the virus reenters the body after suppression therapy would it cause the outbreaks to be as bad as they were before? Forgive me if this is a stupid question.

      Like

  5. TVEC says:

    Hi Bill, I saw in an interview you did today with RollingOut that the symptom reduction went from 3-3.5 fold up to 7-8 fold, which I find to be really exciting! If possible, could you elaborate on this? Thanks. TVEC

    Like

    • Herpes Vaccine Research says:

      Hi TVEC,

      In principle, I like what the author tried to write, but there are about a half-dozen factual errors in that story simply because the author wrote down what he “thought I said” and did not ask me to proof for scientific accuracy. Regarding your query, what I tried to convey is that, as of Sept 20, 2016, “17 participants in the trial who completed the vaccination series reported an average 3.2-fold reduction in herpes symptomatic days per month relative to the two years leading up to their first vaccination.” What I was trying to communicate, which got lost in translation, is that Sept 20 was too early to see the full effects of the vaccination because for the people who started in June 2016, they were only 30 days out from the full effect of the vaccine. The only reason for the Sept 20 cutoff is that I needed 3 weeks to prepare for the SIU Tech Expo……..preliminary data is better tha, no data, so I presented what I had at that point in time.

      The reported 3.2-fold reduction includes “herpes symptomatic days” that occurred during the transition period for trial participants between Shot 1 and Shot 3 where any immunologist knows that the vaccine has not had full time to do its magic and elicit the maximal protective effect. So, what I was trying to convey to the interviewer is that once another 3 months elapse, there will be enough “true post-vaccination months” to exclude the “transition period data” and get down to the real results. What, I anticipate once we are there is an average 7- to 8-fold-reduction in herpes symptomatic days across these 17 trial participants. That is just a ballpark prediction…..we will need to see how the data actually pans out to know for real.

      To illustrate what happened in a single participant (i.e., this is a real result from a real person), that person was immunized three times between April 1, 2016 and June 10, 2016. This person reported the following pattern of herpes symptomatic days:

      – 12 outbreaks per year (menstrual cycle-driven like clockwork) and those OBs lasted 5 – 7 days
      – So, based on 2 years of prior observation, this participant self-reported an average 6 days of OBs over the 24 months prior to vaccination.
      – After Vaccination 1 on April 1, this person reported 6 OB days in April
      – After Vaccination 2 in early May, this person reported 2 OB days in May
      – After Vaccination 3 in early June, this person reported 0 OB days in June
      – 0 OB Days in July
      – 0 OB Days in August
      – 0 OB Days in September
      – 0 OB Days in October

      So, returning to what I said above, those 8 OB days in April and May were included in what I reported in the Tech Expo data because we were still so close to vaccination that I was not comfortable not including the first 3 months of data. However, by March 2017, then I can for all trial participants exclude the “transition period herpes-symptomatic days” to better represent the full magnitude of what the vaccine does for people. Also, with the passage of time, in this person’s case, I will have greater comfort with where the vaccine effect settles out once another 4 or 5 menstrual cycles pass.

      So, nice article in terms of its overall message, but just recognize that not everything written in the article is exactly a faithful representation of what I was trying to communicate.

      – Bill H.

      Like

  6. Dave says:

    Can you please supply data relating to reduction in viral shedding. Without that, impossible to take this study seriously.

    Like

    • Adam UK says:

      From my understanding, the study is foremost to study the efficacy of the live attenuated virus on cronic recurring herpes symptoms i.e. pain, constant outbreaks significantly over what most of the 20% who do have outbreaks experience, the 2% where it is a chronic disorder. What appears to be the case is that there was a 3.2 fold reduction of symptoms initially and from what the good doctor also brought to light was that after the vaccine has taken effect (post vaccine transition) a 7 to 8 fold reduction (that translates to circa 700% reduction in proliferation). When compared to the 50% reduction of shedding achieved by use of suppressive medication, and then combined with use of condoms circa 2% risk of infection annually. Studies indicate that there is a 10% risk for transmission by men to women, reduced to 5% with suppresive drugs and then to 2% with condoms for men, or 1% from women to men (initially 4% without preventative methods). The odds of contracting the virus at this level are very, very low. So when you take into account the initial 3 fold reduction (300%), it could be hoped that shedding effectively becomes a non-issue or significantly lower than current preventative methods can achieve. There then is the release of the preventative vaccine.

      From the current findings, you can take Dr Halfords work very seriously. However there is no doubt detailed data related to viral shedding will be invaluable and something I would also like to see.

      Keep up your great work, I have signed up to an opportunity to be in the trial and more than happy to pay flights / accomodation.

      Like

  7. Guess says:

    Hey Bill Im wondering if the Theravaxhsv2 vaccine reduces symptoms for HSV type 1. Wouldn’t it be possible that HSV type 1 provax vaccine could help reduce symptoms in HSV2. It’s a similar concept in reverse. I assume they could since they are pretty similar viruses.

    Like

  8. Robert Shepherd says:

    Hi Bill, interesting program you’re running. Can you provide some background on how you selected this dose of virus, if there were any safety signals observed in these patients other than the self-reported injection site reactions, and the study endpoints? From what I see in your slides, this was a Phase O/I, open label, non-comparator, single-dose study to assess the safety and efficacy in patient-reported symptoms for Theravax in HSV-2 seropositive adults? Is that how industry would categorise your study design? Cheers, Robert

    Like

  9. parveen says:

    Dr Bill,

    Thank you for the sharing presentation. We have hope alot from your researched.

    We will for commercalize your vaccine once approved.

    Like

  10. Jim says:

    Congrats and thank you Dr Halford!
    I plugged the numbers from your slides into excel and it looks like about 63% reduction in self reported symptoms? Genocea reported 65% reduction in genital lesions after 6 months observations. Admedus recently reported 90% reduction in lesions. Obviously symptoms and lesions are not apples to apples comparison and it’s great that you’re actually differentiating herpes neuralgia from outbreaks. None of the sub unit trials even addressed the neuralgia issue to my knowledge. But what are your thoughts on these numbers? Is this the kind of reduction you expected? Do you anticipate further reduction in symptoms with time or another booster shot? I’m anxiously waiting for viral shedding results from your trials. Thank you again for all your hard work!
    Jim

    Like

  11. TVEC says:

    Hi Bill, first of all, congrats on the trial so far, you deserve it! I know you are getting a million questions so sorry in advance, but here goes: In the histograms showing the comparison of symptoms before and after, what was the criteria for symptoms? In particular, for the “HSV2 GH” subgroup, what qualified as “symptomatic”?

    Like

  12. Halford Fan says:

    Hi Bill,

    Thanks very much for all the information and everything else. The initial results look very promising. Thanks for uploading everything so quickly as well, and also providing a more in depth detail rather than just the 10 minute SIU version. And also for uploading everything so quickly for us!

    I have a couple of questions please:

    What was the reason for 3 out of 20 participants not completing all 3 shots?

    On the HSV Western Blot, how come there looks like less black bands on the Day +70 blot? I would have thought this would be the darkest? And what black bar was this guy in the Recurrent HSV-2 GH chart? (very interesting that he hasn’t had an OB in months)

    Thanks

    Liked by 1 person

    • enceladus_ says:

      I was also curious about the black bands fading on the Western Blot Test at day 70? Also, over time, might there be a need for a booster shot after several years?

      Like

      • SpiralOut says:

        Hi Bill,

        I would also very much like to hear your thoughts on day 70’s blot test appearing less prominent than the previous test!

        Thank you!

        Like

  13. Paul says:

    I just watched the videos, and thank you very much Dr. Halford. My background is in technology, and so I really, really appreciate the organizational startup business approach you’re taking to this.

    My question is, now that you’ve conducted these Phase 1 trials, what are the next steps? Seeking investors to fund Phase 2? Say you had investors lined up right now, what’s the idealized timescale on commercializing Theravax?

    Good luck with your work!

    Liked by 2 people

    • Mark says:

      So what happened in the clinical trial? My computer didn’t allow me to open it. Someone sum up the results. Please god I hope it’s very good news!

      Like

  14. mike suffridge says:

    I have to respectfully disagree with you Dr. Halford ,you are the one who deserves this through your many years of dedicated research.We herpes patients now have to pick up the ball,get off the sidelines and get the word out.I know its still early in the ball game, but I say game on!

    Like

  15. hamerslagblog says:

    Very curious about the near future now. Will more of us get the chance to receive the vaccine soon? Will it be only in St.Kitts or also in other locations?
    Could you give an indication of the cost?

    Thank you!

    Liked by 1 person

  16. Jim says:

    Thank you Dr. Halford, this is wonderful news to hear for many of us who avidly follow your blog and your progress. It is especially encouraging to hear of the findings from the initial trials.

    The absence of participants’ neuralgia subsequent to treatment with the live-attenuated HSV-2 vaccine appears to be consistent with what some of us have suspected – that it is ongoing sub-clinical viral activity responsible for nerve dysfunction and pain, not nerve damage. I always felt the term ‘post’-herpetic neuralgia was a misnomer.

    We have been looking forward to this day, with great hope that you would gain the recognition for your work. I know this day will always be remembered by me, as today here in Thailand, a very sad day as His Majesty the King has passed away. I hope what you have begun there in USA, will raise the bar for sufferers and offer a better future. All the best to you. Jim

    Liked by 2 people

    • Rick says:

      Jim,
      I am glad to see your post. I had not seen any posts from you in a long while and I was concerned about your health.
      This is great news for all of us who have nerve issues. This is so very encouraging! Take care my friend.

      Rick

      Like

  17. hamerslagblog says:

    This is very impressive. Congratulations! Thank you so much for your hard work. It will change our lives! Incredible!
    I hope the vaccine will be available soon. Actually I would buy a ticket for St.Kitt right this very moment and fly asap to get my shots.

    Thank you thank you thank you!!!!!!! (and your team, and your family and friend who support you making this all possible)

    Like

  18. neversurrenderjake says:

    Dr. Halford,

    Thank you for sharing your presentation today. The interim results for your St. Kitts test are very encouraging!! I know I speak for many other long time HSV sufferers in expressing my sincerest my gratitude for all your efforts (including those of the rest of your team) to date.

    Good for you for believing in yourself and never giving in to the nay-sayers. Look forward to getting further updates and learning how we can further support Rational Vaccines.

    Thank you!!!

    Jake

    Liked by 2 people

Comments are closed.