Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial.
Lancet
; 364(9447): 1757-65, 2004.
Article
in En
| MEDLINE
| ID: mdl-15541448
ABSTRACT
BACKGROUND:
Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions.METHODS:
We randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity.FINDINGS:
In the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic.INTERPRETATION:
The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Papillomaviridae
/
Viral Vaccines
/
Uterine Cervical Neoplasms
/
Oncogene Proteins, Viral
/
Papillomavirus Infections
/
Papillomavirus Vaccines
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Female
/
Humans
Language:
En
Journal:
Lancet
Year:
2004
Type:
Article
Affiliation country:
United States