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The development of an effective HSV\u20102 vaccine would significantly impact global health based on the psychological distress caused by genital herpes for some individuals, the risk transmitting the infection from mother to infant, and the elevated risk of acquiring HIV\u20101. Five nonclinical safety studies were conducted with the replication defective HSV529 vaccine, alone or adjuvanted with GLA\u2010SE, and the G103 subunit vaccine containing GLA\u2010SE. A biodistribution study was conducted in guinea pigs to evaluate distribution, persistence, and shedding of HSV529. A preliminary immunogenicity study was conducted in rabbits to demonstrate HSV529\u2010specific humoral response and its enhancement by GLA\u2010SE. Three repeated\u2010dose 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\u2010SE, or G103 containing GLA\u2010SE. Data from these studies show that both vaccines are safe and well tolerated and support the ongoing HSV\u20102 clinical trial in which the two vaccine candidates will be given either sequentially or concomitantly to explore their potential synergistic and incremental effects.<\/jats:p>","DOI":"10.1002\/jat.4404","type":"journal-article","created":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T12:25:02Z","timestamp":1665663902000},"page":"534-556","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Nonclinical safety evaluation of two vaccine candidates for herpes simplex virus type 2 to support combined administration in humans"],"prefix":"10.1002","volume":"43","author":[{"given":"Fabienne","family":"Piras","sequence":"first","affiliation":[{"name":"Sanofi  Marcy l'Etoile France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa M.","family":"Plitnick","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.  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