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Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases.
N Engl J Med 2007; 356(19):1928-43NEJM

Abstract

BACKGROUND

A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18.

METHODS

In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose.

RESULTS

The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31).

CONCLUSIONS

The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. (ClinicalTrials.gov number, NCT00092521 [ClinicalTrials.gov].).

Authors+Show Affiliations

Microbiology and Infectious Diseases Department, Royal Women's Hospital, and the University of Melbourne, Melbourne, Australia. suzanne.garland@rch.org.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17494926

Citation

Garland, Suzanne M., et al. "Quadrivalent Vaccine Against Human Papillomavirus to Prevent Anogenital Diseases." The New England Journal of Medicine, vol. 356, no. 19, 2007, pp. 1928-43.
Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356(19):1928-43.
Garland, S. M., Hernandez-Avila, M., Wheeler, C. M., Perez, G., Harper, D. M., Leodolter, S., ... Koutsky, L. A. (2007). Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. The New England Journal of Medicine, 356(19), pp. 1928-43.
Garland SM, et al. Quadrivalent Vaccine Against Human Papillomavirus to Prevent Anogenital Diseases. N Engl J Med. 2007 May 10;356(19):1928-43. PubMed PMID: 17494926.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. AU - Garland,Suzanne M, AU - Hernandez-Avila,Mauricio, AU - Wheeler,Cosette M, AU - Perez,Gonzalo, AU - Harper,Diane M, AU - Leodolter,Sepp, AU - Tang,Grace W K, AU - Ferris,Daron G, AU - Steben,Marc, AU - Bryan,Janine, AU - Taddeo,Frank J, AU - Railkar,Radha, AU - Esser,Mark T, AU - Sings,Heather L, AU - Nelson,Micki, AU - Boslego,John, AU - Sattler,Carlos, AU - Barr,Eliav, AU - Koutsky,Laura A, AU - ,, PY - 2007/5/15/pubmed PY - 2007/5/18/medline PY - 2007/5/15/entrez SP - 1928 EP - 43 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 356 IS - 19 N2 - BACKGROUND: A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18. METHODS: In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose. RESULTS: The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31). CONCLUSIONS: The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. (ClinicalTrials.gov number, NCT00092521 [ClinicalTrials.gov].). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/17494926/full_citation L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa061760?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -