High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6 11 16 18 L1 virus-like particle vaccine through 5 years of follow-up

• Published in: British journal of cancer Vol. 95; no. 11; pp. 1459 - 1466
• Main Authors: Villa, L L, Costa, R L R, Petta, C A, Andrade, R P, Paavonen, J, Iversen, O-E, Olsson, S-E, Høye, J, Steinwall, M, Riis-Johannessen, G, Andersson-Ellstrom, A, Elfgren, K, Krogh, G von, Lehtinen, M, Malm, C, Tamms, G M, Giacoletti, K, Lupinacci, L, Railkar, R, Taddeo, F J, Bryan, J, Esser, M T, Sings, H L, Saah, A J, Barr, E
• Format: Journal Article
• Language: English
• Published: England Nature Publishing Group 04.12.2006
• Subjects: Adolescent; Adult; Alphapapillomavirus - immunology; antibodies; Antibodies, Viral - blood; cancer; Cancer and Oncology; Cancer och onkologi; cervical; cervical intraepithelial neoplasia (CIN); Cervical Intraepithelial Neoplasia - prevention & control; cervical-cancer; classification; Clinical Medicine; Clinical Study; clinical trial; Condylomata Acuminata - prevention & control; controlled-trial; Double-Blind Method; Female; Follow-Up Studies; genital warts; hpv; Human papillomavirus; Humans; Incidence; infection; intraepithelial neoplasia; Klinisk medicin; Medical and Health Sciences; Medicin och hälsovetenskap; Papillomavirus Infections - epidemiology; Papillomavirus Infections - prevention & control; Papillomavirus Vaccines - immunology; Papillomavirus Vaccines - therapeutic use; population; prophylactic vaccine; recurrent respiratory papillomatosis; Uterine Cervical Dysplasia - prevention & control; Uterine Cervical Neoplasms - prevention & control; Vaginal Smears; Virion - immunology; virus-like particles
• ISSN: 0007-0920; 1532-1827; 1532-1827
• DOI: 10.1038/sj.bjc.6603469

Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18 L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrollment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo recipients (efficacy = 100%; 95% CI:12-100%). Through 5 years, vaccine-induced anti-HPV geometric mean titres remained at or above those following natural infection. In conclusion, a prophylactic quadrivalent HPV vaccine was effective through 5 years for prevention of persistent infection and disease caused by HPV 6/11/16/18. This duration supports vaccination of adolescents and young adults, which is expected to greatly reduce the burden of cervical and genital cancers, precancerous dysplasia, and genital warts.