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

TitleSafety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men.
Publication TypeJournal Article
Year of Publication2010
AuthorsWilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, J Berry M, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM
JournalJ Infect Dis
Volume202
Issue8
Pagination1246-53
Date Published2010 Oct 15
ISSN1537-6613
KeywordsAdult, Anal Canal, Antibodies, Viral, Anus Neoplasms, HIV Infections, HIV-1, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Humans, Male, Middle Aged, Papillomavirus Vaccines
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.

DOI10.1086/656320
Alternate JournalJ. Infect. Dis.
PubMed ID20812850
PubMed Central IDPMC3118428
Grant ListK23 AI 55038 / AI / NIAID NIH HHS / United States
K23 AI055038 / AI / NIAID NIH HHS / United States
K23 AI055038-01 / AI / NIAID NIH HHS / United States
M01 RR000865-26 / RR / NCRR NIH HHS / United States
M01-RR00865 / RR / NCRR NIH HHS / United States
U01 CA121947 / CA / NCI NIH HHS / United States
U01 CA121947-01 / CA / NCI NIH HHS / United States
U01CA121947-01 / CA / NCI NIH HHS / United States
UL1 RR024131 / RR / NCRR NIH HHS / United States
UL1 RR024131 / RR / NCRR NIH HHS / United States
UL1 RR024131-01 / RR / NCRR NIH HHS / United States
UL1 RR024996 / RR / NCRR NIH HHS / United States
UL1 RR024996-01 / RR / NCRR NIH HHS / United States
UL1RR024996 / RR / NCRR NIH HHS / United States