Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions
| العنوان: | Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions |
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| المؤلفون: | Lisa Lupinacci, Eliav Barr, Janine T. Bryan, Kristjan Sigurdsson, Susanne K. Kjaer, Teresa M. Hesley, Finn Egil Skjeldestad, Mauricio Hernández-Ávila, Annemarie R. Thornton, Joakim Dillner, John W. Boslego, Luisa L. Villa, Nubia Muñoz, Evan R. Myers, Steinar Thoresen, Gonzalo Perez, Sven Eric Olsson, Heather L. Sings, Christine K. Gause, Matti Lehtinen, Slawomir Majewski, F. Xavier Bosch, Mark T. Esser, Frank J. Taddeo, Jorma Paavonen, Kevin A. Ault, Patricia J. Garcia, Laura A. Koutsky, Darron R. Brown, Robert J. Kurman, Daron G. Ferris, Hseon Tay Eng |
| المصدر: | New England Journal of Medicine. 356:1915-1927 |
| بيانات النشر: | Massachusetts Medical Society, 2007. |
| سنة النشر: | 2007 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, Time Factors, Adolescent, Population, Human Papilloma Virus Vaccine, Uterine Cervical Neoplasms, HPV vaccines, Adenocarcinoma, Alphapapillomavirus, Cervical intraepithelial neoplasia, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Internal medicine, medicine, Humans, Papillomavirus Vaccines, 030212 general & internal medicine, education, Cervical cancer, Human papillomavirus 16, education.field_of_study, Human papillomavirus 18, business.industry, Gardasil, Papillomavirus Infections, virus diseases, General Medicine, Uterine Cervical Dysplasia, medicine.disease, Vaccine efficacy, female genital diseases and pregnancy complications, 3. Good health, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, DNA, Viral, Female, Cervarix, business, Follow-Up Studies, medicine.drug |
| الوصف: | Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18.In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18.Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31).In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].). |
| تدمد: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa061741 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47b6e9af444406d19b1664edf0d70abc https://doi.org/10.1056/nejmoa061741 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....47b6e9af444406d19b1664edf0d70abc |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
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| DOI: | 10.1056/nejmoa061741 |