Infection Clinical Trial
Official title:
A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells. PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.
OBJECTIVES: Primary - To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men. - To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline. Secondary - To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series. - To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response. - To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline. - To evaluate the oral levels of serum IgA before and after the vaccination series. Tertiary - To evaluate prevalent and incident HPV infections in the anal canal. - To evaluate cytological and histological abnormalities in the anal canal. - To evaluate prevalent and incident HPV infections in the oral cavity. - To compare oral and anal compartmental shedding of HPV before and after vaccination. OUTLINE: This is a multicenter study. Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24. After completion of protocol therapy, patients are followed at 7, 12, and 18 months. ;
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