PMID- 25587221 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20150114 LR - 20200930 IS - 1179-1411 (Print) IS - 1179-1411 (Electronic) IS - 1179-1411 (Linking) VI - 6 DP - 2014 TI - Long-term efficacy and safety of human papillomavirus vaccination. PG - 999-1010 LID - 10.2147/IJWH.S50365 [doi] AB - In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines - bivalent (bHPV) and quadrivalent (qHPV) - are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman's sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish systems for continued monitoring of vaccine immunogenicity, efficacy, and safety over time. FAU - De Vincenzo, Rosa AU - De Vincenzo R AD - Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. FAU - Conte, Carmine AU - Conte C AD - Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. FAU - Ricci, Caterina AU - Ricci C AD - Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. FAU - Scambia, Giovanni AU - Scambia G AD - Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. FAU - Capelli, Giovanni AU - Capelli G AD - Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio, Cassino, Italy. LA - eng PT - Journal Article PT - Review DEP - 20141203 PL - New Zealand TA - Int J Womens Health JT - International journal of women's health JID - 101531698 PMC - PMC4262378 OTO - NOTNLM OT - HPV vaccines OT - adverse events OT - effectiveness EDAT- 2015/01/15 06:00 MHDA- 2015/01/15 06:01 PMCR- 2014/12/03 CRDT- 2015/01/15 06:00 PHST- 2015/01/15 06:00 [entrez] PHST- 2015/01/15 06:00 [pubmed] PHST- 2015/01/15 06:01 [medline] PHST- 2014/12/03 00:00 [pmc-release] AID - ijwh-6-999 [pii] AID - 10.2147/IJWH.S50365 [doi] PST - epublish SO - Int J Womens Health. 2014 Dec 3;6:999-1010. doi: 10.2147/IJWH.S50365. eCollection 2014.