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Sustained efficacy up to 4·5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial
- Source :
- The Lancet. 367:1247-1255
- Publication Year :
- 2006
- Publisher :
- Elsevier BV, 2006.
-
Abstract
- Summary Background Effective vaccination against HPV 16 and HPV 18 to prevent cervical cancer will require a high level of sustained protection against infection and precancerous lesions. Our aim was to assess the long-term efficacy, immunogenicity, and safety of a bivalent HPV-16/18 L1 virus-like particle AS04 vaccine against incident and persistent infection with HPV 16 and HPV 18 and their associated cytological and histological outcomes. Methods We did a follow-up study of our multicentre, double-blind, randomised, placebo-controlled trial reported in 2004. We included women who originally received all three doses of bivalent HPV-16/18 virus-like particle AS04 vaccine (0·5 mL; n=393) or placebo (n=383). We assessed HPV DNA, using cervical samples, and did yearly cervical cytology assessments. We also studied the long-term immunogenicity and safety of the vaccine. Findings More than 98% seropositivity was maintained for HPV-16/18 antibodies during the extended follow-up phase. We noted significant vaccine efficacy against HPV-16 and HPV-18 endpoints: incident infection, 96·9% (95% CI 81·3–99·9); persistent infection: 6 month definition, 94·3 (63·2–99·9); 12 month definition, 100% (33·6–100). In a combined analysis of the initial efficacy and extended follow-up studies, vaccine efficacy of 100% (42·4–100) against cervical intraepithelial neoplasia (CIN) lesions associated with vaccine types. We noted broad protection against cytohistological outcomes beyond that anticipated for HPV 16/18 and protection against incident infection with HPV 45 and HPV 31. The vaccine has a good long-term safety profile. Interpretation Up to 4·5 years, the HPV-16/18 L1 virus-like particle AS04 vaccine is highly immunogenic and safe, and induces a high degree of protection against HPV-16/18 infection and associated cervical lesions. There is also evidence of cross protection.
- Subjects :
- Adult
medicine.medical_specialty
Time Factors
Uterine Cervical Neoplasms
HPV vaccines
Cervical intraepithelial neoplasia
Double-Blind Method
Internal medicine
medicine
Humans
Multicenter Studies as Topic
Papillomavirus Vaccines
Papillomaviridae
Randomized Controlled Trials as Topic
Cervical cancer
business.industry
Gardasil
Papillomavirus Infections
virus diseases
Viral Vaccines
General Medicine
Uterine Cervical Dysplasia
medicine.disease
Vaccine efficacy
female genital diseases and pregnancy complications
Clinical trial
Vaccination
Immunology
Female
Cervarix
business
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 01406736
- Volume :
- 367
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....06068abd9389e1edfb4152e91d4c8d0b