Comparison of the Immunogenicity and Reactogenicity of Cervarix and Gardasil Human Papillomavirus Vaccines in HIV-Infected Adults: A Randomized, Double-Blind Clinical Trial

摘要: Background. We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus (HPV) vaccines in adults infected with immunodeficiency virus (HIV). Methods. This was a double-blind, controlled trial randomizing HIV-positive to receive 3 doses at 0, 1.5, 6 months. Immunogenicity evaluated for up 12 Neutralizing anti–HPV-16/18 antibodies were measured by pseudovirion-based neutralization assay. Laboratory tests diary cards used safety assessment. The HPV-DNA status participants determined before after immunization. Results. Ninety-two included study. Anti–HPV-18 antibody titers higher group 7 No significant differences anti–HPV-16 found among vaccine groups. Among vaccinees, women had anti–HPV-16/ 18 men. sex-specific group. Mild injection site reactions more common than (91.1% vs 69.6%; P = .02). serious adverse events occurred. Conclusions. Both immunogenic well tolerated. Compared Gardasil, induced superior responses HIV-infected women, whereas men difference less pronounced. Clinical Trials Registration. NCT01386164.