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Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases.

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].).

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  • Authors+Show Affiliations

    ,

    Microbiology and Infectious Diseases Department, Royal Women's Hospital, and the University of Melbourne, Melbourne, Australia. suzanne.garland@rch.org.au

    , , , , , , , , , , , , , , , , , ,

    Source

    The New England journal of medicine 356:19 2007 May 10 pg 1928-43

    MeSH

    Adenocarcinoma
    Adolescent
    Adult
    Alphapapillomavirus
    Carcinoma in Situ
    Condylomata Acuminata
    DNA, Viral
    Double-Blind Method
    Female
    Follow-Up Studies
    Genital Neoplasms, Female
    Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
    Humans
    Papillomavirus Infections
    Papillomavirus Vaccines

    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 - https://www.nejm.org/doi/10.1056/NEJMoa061760?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -