Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases

Suzanne M. Garland, Mauricio Hernandez-Avila, Cosette M. Wheeler, Gonzalo Perez, Diane M. Harper, Sepp Leodolter, Grace W.K. Tang, Daron Gale Ferris, Marc Steben, Janine Bryan, Frank J. Taddeo, Radha Railkar, Mark T. Esser, Heather L. Sings, Micki Nelson, John Boslego, Carlos Sattler, Eliav Barr, Laura A. Koutsky

Research output: Contribution to journalArticle

1369 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1928-1943
Number of pages16
JournalNew England Journal of Medicine
Volume356
Issue number19
DOIs
StatePublished - May 10 2007

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Papillomavirus Vaccines
Vaccines
Human papillomavirus 11
Human papillomavirus 6
Placebos
Incidence
Confidence Intervals
Condylomata Acuminata
Neoplasms
Intention to Treat Analysis
Cervical Intraepithelial Neoplasia
Population
Vaccination
Infection

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. New England Journal of Medicine, 356(19), 1928-1943. https://doi.org/10.1056/NEJMoa061760

Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. / Garland, Suzanne M.; Hernandez-Avila, Mauricio; Wheeler, Cosette M.; Perez, Gonzalo; Harper, Diane M.; Leodolter, Sepp; Tang, Grace W.K.; Ferris, Daron Gale; Steben, Marc; Bryan, Janine; Taddeo, Frank J.; Railkar, Radha; Esser, Mark T.; Sings, Heather L.; Nelson, Micki; Boslego, John; Sattler, Carlos; Barr, Eliav; Koutsky, Laura A.

In: New England Journal of Medicine, Vol. 356, No. 19, 10.05.2007, p. 1928-1943.

Research output: Contribution to journalArticle

Garland, SM, Hernandez-Avila, M, Wheeler, CM, Perez, G, Harper, DM, Leodolter, S, Tang, GWK, Ferris, DG, Steben, M, Bryan, J, Taddeo, FJ, Railkar, R, Esser, MT, Sings, HL, Nelson, M, Boslego, J, Sattler, C, Barr, E & Koutsky, LA 2007, 'Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases', New England Journal of Medicine, vol. 356, no. 19, pp. 1928-1943. https://doi.org/10.1056/NEJMoa061760
Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. New England Journal of Medicine. 2007 May 10;356(19):1928-1943. https://doi.org/10.1056/NEJMoa061760
Garland, Suzanne M. ; Hernandez-Avila, Mauricio ; Wheeler, Cosette M. ; Perez, Gonzalo ; Harper, Diane M. ; Leodolter, Sepp ; Tang, Grace W.K. ; Ferris, Daron Gale ; Steben, Marc ; Bryan, Janine ; Taddeo, Frank J. ; Railkar, Radha ; Esser, Mark T. ; Sings, Heather L. ; Nelson, Micki ; Boslego, John ; Sattler, Carlos ; Barr, Eliav ; Koutsky, Laura A. / Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. In: New England Journal of Medicine. 2007 ; Vol. 356, No. 19. pp. 1928-1943.
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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.",
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AU - Leodolter, Sepp

AU - Tang, Grace W.K.

AU - Ferris, Daron Gale

AU - Steben, Marc

AU - Bryan, Janine

AU - Taddeo, Frank J.

AU - Railkar, Radha

AU - Esser, Mark T.

AU - Sings, Heather L.

AU - Nelson, Micki

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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.

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