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Bivalent? by Vical


sdl35

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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

06/20/2016

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.

 

http://www.vical.com/investors/news-releases/News-Release-Details/2016/Vicals-Phase-12-Trial-Data-Presented-at-ASM-2016-Shows-Bivalent-Vaccine-Imparts-Reduction-in-Genital-Herpes-Lesions-Durable-to-9-Months/default.aspx?print=1

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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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