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Bivalent? by Vical


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i believe member Dan S H is in the clinical trial for this, if i'm right the vaccine is called vcl-hb01 by Vical. im not sure how it did in phase 1 maybe someone in the forum can help.....

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Vical’s Phase 1/2 Trial Data Presented at ASM 2016 Shows Bivalent Vaccine Imparts Reduction in Genital Herpes Lesions Durable to 9 Months


Vical plans to advance the bivalent vaccine to a Phase 2 trial in 2016 and maintains current financial guidance for 2016

SAN DIEGO, June 20, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) presented data from the randomized, double-blind, placebo-controlled Phase 1/2 clinical trial of its therapeutic genital herpes vaccine in symptomatic herpes simplex virus type 2 (HSV-2) infected patients in an oral late-breaker presentation at the American Society for Microbiology (ASM/ICAAC) Microbe 2016 meeting held in Boston. The slides presented by Mammen P. "Anza" Mammen, Jr., M.D., Vical’s Vice President, Clinical Vaccines, will be accessible on Vical’s website.

The per protocol study analyses included 131 evaluable patients: 54 receiving the monovalent (gD) vaccine, 56 receiving the bivalent vaccine (gD + UL46) and 21 receiving placebo. Initial top line 3-month data announced in June 2015 showed that neither the monovalent nor the bivalent vaccine met the primary endpoint of viral shedding rate reduction from baseline. However, the bivalent vaccine achieved statistically significant reduction in a prospectively defined secondary endpoint of genital lesion rate at 3 months versus baseline (-49%, p = 0.031). In the 9-month analysis presented today, the statistically significant reduction in lesion rate compared to baseline for the bivalent vaccine was sustained (-57%, p = 0.009). Furthermore, at the 9-month time point, the bivalent vaccine showed a favorable trend in recurrence rate, time to first recurrence, and proportion of patients who are recurrence-free. Vical’s vaccines elicited significant increases in antigen-specific interferon gamma producing T cells, indicating biologic activity.

An independent Safety Monitoring Board reviewed all adverse events (AEs) and deemed the vaccines to be safe and tolerable in this trial. No serious adverse events, Grade 4 AEs, or AEs of special interest related to vaccinations were observed during the study period. Grade 3 AEs were reported in 13% of subjects, the most common of which were fatigue and injection site pain.



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Very good , in 2025 we could get better treatment or vaccine which will reduce the severity of the ob's I will be almost 50 years so I could live few years in peice and dayig without thinking about HSV 

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to think a vaccine with such crappy results is spending the money to go to phase 2 makes my heart sink, they must truly believe there product will thrive in the market in 8-10 years. i feel so gutted. 

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I wasn't able to get into this study.  I was not infected long enough.  They said I could come back in phase 3 in a few years.  They said it's only for One not viral shedding.  

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    • FirstTimeUser
      @WilsoInAuswould appreciate your thoughts as have seen you comment quite a bit before!
    • Marlena
      Good morning. My name is Marlena and I come from Poland. Sorry, my English is average. For two years I have been in a relationship with a man, for a year and a half I have been struggling with intimate problems. On average, my intimate condition is getting worse every month. Then I feel itching, redness, swelling around the entrance to the vagina, small blisters (not always). Most often it is only red and swollen, itches and then disappears. This state lasts 3-4 days. I come from a small town, doctors don't know what it is. They say it's 'skin irritation'. They prescribe moisturizing creams with lactic acid, probiotics. It doesn't help. I did a blood test for HSV on my own, which is very expensive in Poland, but it does not separate HSV1 from HSV2. The doctor, when he shows these results, says that it's not herpes, but irritation. I would like to add that in the past I suffered from herpes on the lips, then it was a 'scab'. There has never been a scab in an intimate area. Sometimes there are blisters that last 1-2 days, but not always. So what do high blood test results mean? I would like to add that in Poland people do not talk about the HSV virus. It's just that sometimes someone has it on their lips and that's it. Results translation: IgM HSV 1/2: questionable IgG HSV 1/2: result above the measuring range https://files.fm/f/4cpu7uee4  
    • FirstTimeUser
      This is my first time posting here. Im generally pretty anxious when it comes to anything to do with health conditions etc. For context I have had jock itch and fungal infections previously on my buttcrack. I have had 0 new sexual partners and I am not concerned about my girlfriend cheating at all. 4 days ago my balls began itching and red pretty much all over, as you can see some general flakeyness and what looks to be a lesion I noticed on Monday when I checked them out. My partner and I do get cold sores from time to time so the anxious part of me is concerned this could be herpes, but at the same time could be some sort of fungal infection. My doctor cant see me until tomorrow so I just have to worry until then. There is no pain and nothing on the penis or anywhere else, just general itchiness. Any ideas if this is herpes or not?  
    • Jeremy Spokein
      Yes, but every married person who I found out about that has this waited 6-8 months into the relationship to disclose it. But maybe you're right. If I had told her 6-7 months in, she'd still have Googled it and flipped out, and maybe it would have been harder then. I don't know. I don't see myself going through this level of pain and rejection so easily next time. I really don't. I'm taking the meds. I use protection. It's been almost a decade since I've had it so I'm not worried about shedding or passing it on so easily. British studies confirm that the first 2 years are the most contagious and we're passed that. I'm just over this. I've never been in so much emotional pain in my life.
    • Possiblehypercon11
      @WilsoInAus would really appreciate your input please. Kinda freaking out lol. 
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