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Journal: Nonclinical safety evaluation of two vaccine candidates for Herpes Simplex Virus type 2 to support combined administration in humans. (Pubmed Central) - Mar 21, 2023 Three repeated-dose toxicity studies, one in guinea pigs and two in rabbits, were conducted to assess systemic toxicity and local tolerance of HSV529, alone or adjuvanted with GLA-SE, or G103 containing GLA-SE. Data from these studies show that both vaccines are safe and well tolerated and support the ongoing HSV-2 clinical trial in which the two vaccine candidates will be given either sequentially or concomitantly to explore their potential synergistic and incremental effects.
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Trial completion: HSV529 Vaccine in HSV-2 Seropositive Adults (clinicaltrials.gov) - Jan 14, 2019 P1, N=10, Completed, The transition from nano-flow to ultra-performance driven chromatography was found to improve method robustness without compromising the sensitivity of the assay. Active, not recruiting --> Completed
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Enrollment closed: HSV529 Vaccine in HSV-2 Seropositive Adults (clinicaltrials.gov) - Mar 2, 2016 P1, N=10, Active, not recruiting, Trial primary completion date: Apr 2016 --> Nov 2016 Recruiting --> Active, not recruiting
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Enrollment open: HSV529 Vaccine in HSV-2 Seropositive Adults (clinicaltrials.gov) - Nov 8, 2015 P1, N=10, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
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