Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old

Richard J. Hillman, Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone, Edson D. Moreira, Eftyhia Vardas, Carlos Aranda, Heiko Jessen, Daron G. Ferris, Francois Coutlee, J. Brooke Marshall, Scott Vuocolo, Richard M. Haupt, Dalya Guris, Elizabeth I.O. Garner

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2%) seroconverted for vaccine HPV types by month 7. At month 36, 88.9%, 94.0%, 97.9%, and 57.0% of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.

Original languageEnglish (US)
Pages (from-to)261-267
Number of pages7
JournalClinical and Vaccine Immunology
Volume19
Issue number2
DOIs
StatePublished - Feb 1 2012

Fingerprint

Human papillomavirus 11
Human papillomavirus 6
Papillomavirus Vaccines
Vaccines
Warts
Papillomavirus Infections
Vaccination
Virus-Like Particle Vaccines
Antibodies
Mouth Neoplasms
Heterosexuality
Immunoassay
Antibody Formation
Neoplasms
Placebos
Safety
Infection
Serum

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Clinical Biochemistry
  • Microbiology (medical)

Cite this

Hillman, R. J., Giuliano, A. R., Palefsky, J. M., Goldstone, S., Moreira, E. D., Vardas, E., ... Garner, E. I. O. (2012). Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old. Clinical and Vaccine Immunology, 19(2), 261-267. https://doi.org/10.1128/CVI.05208-11

Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old. / Hillman, Richard J.; Giuliano, Anna R.; Palefsky, Joel M.; Goldstone, Stephen; Moreira, Edson D.; Vardas, Eftyhia; Aranda, Carlos; Jessen, Heiko; Ferris, Daron G.; Coutlee, Francois; Marshall, J. Brooke; Vuocolo, Scott; Haupt, Richard M.; Guris, Dalya; Garner, Elizabeth I.O.

In: Clinical and Vaccine Immunology, Vol. 19, No. 2, 01.02.2012, p. 261-267.

Research output: Contribution to journalArticle

Hillman, RJ, Giuliano, AR, Palefsky, JM, Goldstone, S, Moreira, ED, Vardas, E, Aranda, C, Jessen, H, Ferris, DG, Coutlee, F, Marshall, JB, Vuocolo, S, Haupt, RM, Guris, D & Garner, EIO 2012, 'Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old', Clinical and Vaccine Immunology, vol. 19, no. 2, pp. 261-267. https://doi.org/10.1128/CVI.05208-11
Hillman, Richard J. ; Giuliano, Anna R. ; Palefsky, Joel M. ; Goldstone, Stephen ; Moreira, Edson D. ; Vardas, Eftyhia ; Aranda, Carlos ; Jessen, Heiko ; Ferris, Daron G. ; Coutlee, Francois ; Marshall, J. Brooke ; Vuocolo, Scott ; Haupt, Richard M. ; Guris, Dalya ; Garner, Elizabeth I.O. / Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old. In: Clinical and Vaccine Immunology. 2012 ; Vol. 19, No. 2. pp. 261-267.
@article{ab9801a79ac645e889aceaaff3fda654,
title = "Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old",
abstract = "Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2{\%}) seroconverted for vaccine HPV types by month 7. At month 36, 88.9{\%}, 94.0{\%}, 97.9{\%}, and 57.0{\%} of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.",
author = "Hillman, {Richard J.} and Giuliano, {Anna R.} and Palefsky, {Joel M.} and Stephen Goldstone and Moreira, {Edson D.} and Eftyhia Vardas and Carlos Aranda and Heiko Jessen and Ferris, {Daron G.} and Francois Coutlee and Marshall, {J. Brooke} and Scott Vuocolo and Haupt, {Richard M.} and Dalya Guris and Garner, {Elizabeth I.O.}",
year = "2012",
month = "2",
day = "1",
doi = "10.1128/CVI.05208-11",
language = "English (US)",
volume = "19",
pages = "261--267",
journal = "Clinical and Vaccine Immunology",
issn = "1556-6811",
publisher = "American Society for Microbiology",
number = "2",

}

TY - JOUR

T1 - Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old

AU - Hillman, Richard J.

AU - Giuliano, Anna R.

AU - Palefsky, Joel M.

AU - Goldstone, Stephen

AU - Moreira, Edson D.

AU - Vardas, Eftyhia

AU - Aranda, Carlos

AU - Jessen, Heiko

AU - Ferris, Daron G.

AU - Coutlee, Francois

AU - Marshall, J. Brooke

AU - Vuocolo, Scott

AU - Haupt, Richard M.

AU - Guris, Dalya

AU - Garner, Elizabeth I.O.

PY - 2012/2/1

Y1 - 2012/2/1

N2 - Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2%) seroconverted for vaccine HPV types by month 7. At month 36, 88.9%, 94.0%, 97.9%, and 57.0% of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.

AB - Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2%) seroconverted for vaccine HPV types by month 7. At month 36, 88.9%, 94.0%, 97.9%, and 57.0% of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.

UR - http://www.scopus.com/inward/record.url?scp=84856473763&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84856473763&partnerID=8YFLogxK

U2 - 10.1128/CVI.05208-11

DO - 10.1128/CVI.05208-11

M3 - Article

C2 - 22155768

AN - SCOPUS:84856473763

VL - 19

SP - 261

EP - 267

JO - Clinical and Vaccine Immunology

JF - Clinical and Vaccine Immunology

SN - 1556-6811

IS - 2

ER -