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

L L Villa, R L R Costa, C A Petta, R P Andrade, J Paavonen, O-E Iversen, S-E Olsson, J Høye, M Steinwall, G Riis-Johannessen, A Andersson-Ellstrom, K Elfgren, G von Krogh, M Lehtinen, C Malm, G M Tamms, K Giacoletti, L Lupinacci, R Railkar, F J Taddeo, J Bryan, M T Esser, H L Sings, A J Saah, E Barr, L L Villa, R L R Costa, C A Petta, R P Andrade, J Paavonen, O-E Iversen, S-E Olsson, J Høye, M Steinwall, G Riis-Johannessen, A Andersson-Ellstrom, K Elfgren, G von Krogh, M Lehtinen, C Malm, G M Tamms, K Giacoletti, L Lupinacci, R Railkar, F J Taddeo, J Bryan, M T Esser, H L Sings, A J Saah, E Barr

Abstract

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.

Figures

Figure 1
Figure 1
Trial design. Follow-up time for each woman in each study phase varies dependent on when she completed the last study visit. Discontinuations through month 36 can be found in Villa et al (2005).

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Source: PubMed

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