Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial
| Autor: | Gretchen M. Tamms, Carlos Alberto Petta, Kevin A. Ault, Eliav Barr, Matti Lehtinen, Kathrin U. Jansen, Finn Egil Skjeldestad, Diane M. Harper, Mark T. Esser, Cosette M. Wheeler, Christian Malm, Radha Railkar, Luisa L. Villa, Darron R. Brown, Ronaldo L.R. Costa, Frank J. Taddeo, Heather L. Sings, Brigitte M. Ronnett, Robert J. Kurman, Lisa Lupinacci, Rosires Pereira de Andrade, Anna R. Giuliano, Alex Ferenczy, Jimmy Yu, Sven Eric Olsson, Mark H. Stoler, Margareta Steinwall, Alfred Saah, Laura A. Koutsky |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent Uterine Cervical Neoplasms HPV vaccines Cervical intraepithelial neoplasia Antibodies Viral Genital warts Placebos Double-Blind Method Internal medicine medicine Humans Papillomavirus Vaccines Papillomaviridae Cervical cancer Gynecology biology business.industry Gardasil Papillomavirus Infections HPV infection virus diseases Viral Vaccines Oncogene Proteins Viral medicine.disease biology.organism_classification Uterine Cervical Dysplasia Tumor Virus Infections Oncology Capsid Proteins Female Cervarix business medicine.drug |
| Zdroj: | The Lancet. Oncology. 6(5) |
| ISSN: | 1470-2045 |
| Popis: | Summary Background A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods 277 young women (mean age 20·2 years [SD 1·7]) were randomly assigned to quadrivalent HPV (20 μg type 6, 40 μg type 11, 40 μg type 16, and 20 μg type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20·0 years [1·7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71–97, p Interpretation A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types. Published online April 7, 2005 DOI 10.1016/S1470-2045(05)70101-7 |
| Databáze: | OpenAIRE |
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