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.

Trial registration: ClinicalTrials.gov NCT00513526.

Conflict of interest statement

Potential Conflicts of Interest:

Drs. Lee, Aboulafia, Berry, Cohn, Mitsuyasu, Ms. Lensing, and Ms. Jay have no financial disclosures to report. Dr. Wilkin’s employer, Weill-Cornell Medical College, has received grant funding from Merck for research-related costs of clinical trials for which he was the Cornell PI. Dr. Stier was on the speaker’s bureau for Merck until 2008. Dr. Einstein advised or participated in educational speaking activities, but did not receive an honorarium, from Merck. In specific cases, his hospital, Montefiore Medical Center has received payment for his time spent for these activities. Montefiore has received grant funding from Merck for research-related costs of clinical trials for which he was Montefiore PI. Dr. Goldstone has received grant funding from Merck for research-related costs of clinical trials conducted Laser Surgery Care. He has served as a consultant and a paid speaker for Merck. He has received grant support from Qiagen. Dr. Saah is an employee of Merck Laboratories and owns stock in Merck Laboratories. Dr. Palefsky has served as a consultant for Merck. His employer, University of California San Francisco, has received grant funding from Merck for advisory board activities and research-related costs of clinical trials for which he was the USCF PI.

Figures

Figure 1. AMC052 Study Flow for All Participants who gave Informed Consent

Sero=detection of type-specific serum anti-HPV antibodies above the assay cutoff; DNA=detection of type-specific anal HPV DNA by PCR.