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 H.
AU - Saah, Alfred
AU - Mitsuyasu, Ronald T.
AU - Palefsky, Joel M.
N1 - Funding Information:
Potential conflicts of interest: Weill-Cornell Medical College has received grant funding from Merck for research-related costs of clinical trials for which T.W. was the primary investigator. E.A.S. has served on the speaker’s bureau for Merck. M.H.E. has advised or participated in educational speaking activities but not received an honorarium from Merck; Montefiore Medical Center has received payment for time spent by M.H.E. for these activities; Montefiore Medical Center has received grant funding from Merck for research-related costs of clinical trials for which M.H.E. was primary investigator. S.E.G. has received grant funding from Merck for research-related costs of clinical trials conducted for Laser Surgery Care, has served as a consultant and a paid speaker for Merck, and has received grant support from Qiagen. A.S. is an employee of Merck Laboratories and owns stock in Merck Laboratories. J.M.P. has served as a consultant for Merck; University of California at San Francisco has received grant funding from Merck for advisory board activities of J.M.P. and for research-related costs of clinical trials for which J.M.P. was the primary investigator. All other authors: none reported.
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
SN - 0022-1899
VL - 202
SP - 1246
EP - 1253
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 8
ER -