Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men

Timothy Wilkin, Jeannette Y. Lee, Shelly Y. Lensing, Elizabeth A. Stier, Stephen E. Goldstone, J. Michael Berry, Naomi Jay, David Aboulafia, David L. Cohn, Mark Einstein, Alfred Saah, Ronald T. Mitsuyasu, Joel M. Palefsky

Research output: Contribution to journalArticle

150 Citations (Scopus)

Abstract

Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526.

Original languageEnglish (US)
Pages (from-to)1246-1253
Number of pages8
JournalJournal of Infectious Diseases
Volume202
Issue number8
DOIs
StatePublished - Oct 15 2010
Externally publishedYes

Fingerprint

Papillomavirus Vaccines
HIV-1
Safety
Anus Neoplasms
Vaccination
Vaccines
Clinical Trials
Human papillomavirus 11
Human papillomavirus 6
Cancer Vaccines
CD4 Lymphocyte Count
Multicenter Studies
Cell Biology
Neoplasms
Histology
Acquired Immunodeficiency Syndrome
History
RNA

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Wilkin, T., Lee, J. Y., Lensing, S. Y., Stier, E. A., Goldstone, S. E., Berry, J. M., ... Palefsky, J. M. (2010). Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. Journal of Infectious Diseases, 202(8), 1246-1253. https://doi.org/10.1086/656320
Wilkin, Timothy ; Lee, Jeannette Y. ; Lensing, Shelly Y. ; Stier, Elizabeth A. ; Goldstone, Stephen E. ; Berry, J. Michael ; Jay, Naomi ; Aboulafia, David ; Cohn, David L. ; Einstein, Mark ; Saah, Alfred ; Mitsuyasu, Ronald T. ; Palefsky, Joel M. / Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. In: Journal of Infectious Diseases. 2010 ; Vol. 202, No. 8. pp. 1246-1253.
@article{873a4c899be243b6b5e9a0d340b68770,
title = "Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men",
abstract = "Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98{\%}] of 60), type 11 (67 [99{\%}] of 68), type 16 (62 [100{\%}] of 62), and type 18 (74 [95{\%}] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526.",
author = "Timothy Wilkin and Lee, {Jeannette Y.} and Lensing, {Shelly Y.} and Stier, {Elizabeth A.} and Goldstone, {Stephen E.} and Berry, {J. Michael} and Naomi Jay and David Aboulafia and Cohn, {David L.} and Mark Einstein and Alfred Saah and Mitsuyasu, {Ronald T.} and Palefsky, {Joel M.}",
year = "2010",
month = "10",
day = "15",
doi = "10.1086/656320",
language = "English (US)",
volume = "202",
pages = "1246--1253",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "8",

}

Wilkin, T, Lee, JY, Lensing, SY, Stier, EA, Goldstone, SE, Berry, JM, Jay, N, Aboulafia, D, Cohn, DL, Einstein, M, Saah, A, Mitsuyasu, RT & Palefsky, JM 2010, 'Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men', Journal of Infectious Diseases, vol. 202, no. 8, pp. 1246-1253. https://doi.org/10.1086/656320

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. / Wilkin, Timothy; Lee, Jeannette Y.; Lensing, Shelly Y.; Stier, Elizabeth A.; Goldstone, Stephen E.; Berry, J. Michael; Jay, Naomi; Aboulafia, David; Cohn, David L.; Einstein, Mark; Saah, Alfred; Mitsuyasu, Ronald T.; Palefsky, Joel M.

In: Journal of Infectious Diseases, Vol. 202, No. 8, 15.10.2010, p. 1246-1253.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men

AU - Wilkin, Timothy

AU - Lee, Jeannette Y.

AU - Lensing, Shelly Y.

AU - Stier, Elizabeth A.

AU - Goldstone, Stephen E.

AU - Berry, J. Michael

AU - Jay, Naomi

AU - Aboulafia, David

AU - Cohn, David L.

AU - Einstein, Mark

AU - Saah, Alfred

AU - Mitsuyasu, Ronald T.

AU - Palefsky, Joel M.

PY - 2010/10/15

Y1 - 2010/10/15

N2 - Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526.

AB - Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526.

UR - http://www.scopus.com/inward/record.url?scp=77956984657&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77956984657&partnerID=8YFLogxK

U2 - 10.1086/656320

DO - 10.1086/656320

M3 - Article

C2 - 20812850

AN - SCOPUS:77956984657

VL - 202

SP - 1246

EP - 1253

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 8

ER -

Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM et al. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. Journal of Infectious Diseases. 2010 Oct 15;202(8):1246-1253. https://doi.org/10.1086/656320