{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T08:28:13Z","timestamp":1767860893333,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2010,9,10]],"date-time":"2010-09-10T00:00:00Z","timestamp":1284076800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Birth Defects Research Pt B"],"published-print":{"date-parts":[[2010,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>BACKGROUND:<\/jats:bold> Human papillomavirus (HPV) infection is one of the most common sexually transmitted diseases in both men and women. A recently developed quadrivalent HPV vaccine, Gardasil<jats:sup>\u00ae<\/jats:sup>, has been shown to be highly effective in the prevention of several HPV\u2010mediated diseases. The objective of the present study was to evaluate the potential effects of the vaccine on male fertility including reproductive performance, sperm evaluations, and histology of the testes. In addition, anti\u2010HPV antibodies were measured during the study. <jats:bold>METHODS:<\/jats:bold> Group 1 (30 male rats) received the full human dose of vaccine (0.5\u2009mL, \u223c200\u2010fold excess based on body weight) by intramuscular injection at 6 weeks, 3 weeks, and 3 days prior to cohabitation. Group 2 males received only 1 dose at 3 days prior to cohabitation. Additional groups (20 male rats each) were administered PBS or Merck Aluminum Adjuvant similarly to Group 1. Ten males in the vaccine\u2010treated groups were bled for immunogenicity assays after each dose. Twenty males per group were mated to untreated female rats. Cesarean sections were performed on Gestation Day 15 or 16. Cohabited males were necropsied and sperm count and motility were evaluated. <jats:bold>RESULTS:<\/jats:bold> There were no unscheduled deaths during the study and no evidence of toxicity in vaccine\u2010treated male rats. The vaccine induced a specific antibody response to the 4 HPV types after each injection. There were no effects on the cesarean\u2010section parameters of females or reproductive parameters of the cohabited male rats, including histomorphology of testes and epididymis, sperm count, and sperm motility. <jats:bold>CONCLUSIONS:<\/jats:bold> These results demonstrate that this quadrivalent HPV vaccine had no detectable adverse effects on routine measures of male fertility in rats. <jats:italic>Birth Defects Res (Part B)<\/jats:italic> 89:376\u2013381, 2010. \u00a9 2010 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/bdrb.20259","type":"journal-article","created":{"date-parts":[[2010,9,10]],"date-time":"2010-09-10T14:55:33Z","timestamp":1284130533000},"page":"376-381","source":"Crossref","is-referenced-by-count":15,"title":["Lack of effects on male fertility from a quadrivalent HPV vaccine in Sprague\u2010Dawley rats"],"prefix":"10.1002","volume":"89","author":[{"given":"L. David","family":"Wise","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cindy J.","family":"Pauley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bindhu","family":"Michael","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jayanthi J.","family":"Wolf","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2010,9,10]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3181faac7c"},{"key":"e_1_2_6_3_1","doi-asserted-by":"crossref","first-page":"S2","DOI":"10.1097\/00007435-199904001-00002","article-title":"Estimates of the incidence and prevalence of sexually transmitted diseases in the United States. American Social Health Association Panel","volume":"26","author":"Cates W","year":"1999","journal-title":"Sex Transm Dis"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6600688"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e3181c2a122"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1086\/507432"},{"key":"e_1_2_6_7_1","unstructured":"FDA.2006. Guidance for Industry. 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