Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males

Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone, Edson D. Moreira, Mary E. Penny, Carlos Aranda, Eftyhia Vardas, Harald Moi, Heiko Jessen, Richard Hillman, Yen Hwa Chang, Daron Gale Ferris, Danielle Rouleau, Janine Bryan, J. Brooke Marshall, Scott Vuocolo, Eliav Barr, David Radley, Richard M. Haupt, Dalya Guris

Research output: Contribution to journalArticle

633 Citations (Scopus)

Abstract

Background: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. Methods: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. Results: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). Conclusions: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.)

Original languageEnglish (US)
Pages (from-to)401-411
Number of pages11
JournalNew England Journal of Medicine
Volume364
Issue number5
DOIs
StatePublished - Feb 3 2011

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Papillomavirus Vaccines
Papillomavirus Infections
Human papillomavirus 11
Human papillomavirus 6
Confidence Intervals
Placebos
Population
Vaccines
Infection
Vaccination
Safety
Pain
Injections
DNA
Incidence

ASJC Scopus subject areas

  • Medicine(all)

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Giuliano, A. R., Palefsky, J. M., Goldstone, S., Moreira, E. D., Penny, M. E., Aranda, C., ... Guris, D. (2011). Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. New England Journal of Medicine, 364(5), 401-411. https://doi.org/10.1056/NEJMoa0909537

Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. / Giuliano, Anna R.; Palefsky, Joel M.; Goldstone, Stephen; Moreira, Edson D.; Penny, Mary E.; Aranda, Carlos; Vardas, Eftyhia; Moi, Harald; Jessen, Heiko; Hillman, Richard; Chang, Yen Hwa; Ferris, Daron Gale; Rouleau, Danielle; Bryan, Janine; Marshall, J. Brooke; Vuocolo, Scott; Barr, Eliav; Radley, David; Haupt, Richard M.; Guris, Dalya.

In: New England Journal of Medicine, Vol. 364, No. 5, 03.02.2011, p. 401-411.

Research output: Contribution to journalArticle

Giuliano, AR, Palefsky, JM, Goldstone, S, Moreira, ED, Penny, ME, Aranda, C, Vardas, E, Moi, H, Jessen, H, Hillman, R, Chang, YH, Ferris, DG, Rouleau, D, Bryan, J, Marshall, JB, Vuocolo, S, Barr, E, Radley, D, Haupt, RM & Guris, D 2011, 'Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males', New England Journal of Medicine, vol. 364, no. 5, pp. 401-411. https://doi.org/10.1056/NEJMoa0909537
Giuliano AR, Palefsky JM, Goldstone S, Moreira ED, Penny ME, Aranda C et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. New England Journal of Medicine. 2011 Feb 3;364(5):401-411. https://doi.org/10.1056/NEJMoa0909537
Giuliano, Anna R. ; Palefsky, Joel M. ; Goldstone, Stephen ; Moreira, Edson D. ; Penny, Mary E. ; Aranda, Carlos ; Vardas, Eftyhia ; Moi, Harald ; Jessen, Heiko ; Hillman, Richard ; Chang, Yen Hwa ; Ferris, Daron Gale ; Rouleau, Danielle ; Bryan, Janine ; Marshall, J. Brooke ; Vuocolo, Scott ; Barr, Eliav ; Radley, David ; Haupt, Richard M. ; Guris, Dalya. / Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 5. pp. 401-411.
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abstract = "Background: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. Methods: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. Results: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2{\%} (95{\%} confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5{\%} (95{\%} CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4{\%} (95{\%} CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8{\%} (95{\%} CI, 36.0 to 57.6) and 27.1{\%} (95{\%} CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6{\%} (97.5{\%} CI, 73.4 to 92.9) and 44.7{\%} (95{\%} CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57{\%} vs. 51{\%}, P<0.001). Conclusions: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.)",
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T1 - Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males

AU - Giuliano, Anna R.

AU - Palefsky, Joel M.

AU - Goldstone, Stephen

AU - Moreira, Edson D.

AU - Penny, Mary E.

AU - Aranda, Carlos

AU - Vardas, Eftyhia

AU - Moi, Harald

AU - Jessen, Heiko

AU - Hillman, Richard

AU - Chang, Yen Hwa

AU - Ferris, Daron Gale

AU - Rouleau, Danielle

AU - Bryan, Janine

AU - Marshall, J. Brooke

AU - Vuocolo, Scott

AU - Barr, Eliav

AU - Radley, David

AU - Haupt, Richard M.

AU - Guris, Dalya

PY - 2011/2/3

Y1 - 2011/2/3

N2 - Background: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. Methods: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. Results: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). Conclusions: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.)

AB - Background: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. Methods: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. Results: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). Conclusions: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.)

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