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- Title
Comparison of the Immunogenicity and Reactogenicity of Cervarix and Gardasil Human Papillomavirus Vaccines in HIV-Infected Adults: A Randomized, Double-Blind Clinical Trial.
- Authors
Toft, Lars; Storgaard, Merete; Müller, Martin; Sehr, Peter; Bonde, Jesper; Tolstrup, Martin; Østergaard, Lars; Søgaard, Ole S.
- Abstract
Background. We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus (HPV) vaccines in adults infected with the human immunodeficiency virus (HIV).Methods. This was a double-blind, controlled trial randomizing HIV-positive adults to receive 3 doses of Cervarix or Gardasil at 0, 1.5, and 6 months. Immunogenicity was evaluated for up to 12 months. Neutralizing anti–HPV-16/18 antibodies were measured by pseudovirion-based neutralization assay. Laboratory tests and diary cards were used for safety assessment. The HPV-DNA status of the participants was determined before and after immunization.Results. Ninety-two participants were included in the study. Anti–HPV-18 antibody titers were higher in the Cervarix group compared with the Gardasil group at 7 and 12 months. No significant differences in anti–HPV-16 antibody titers were found among vaccine groups. Among Cervarix vaccinees, women had higher anti–HPV-16/18 antibody titers compared to men. No sex-specific differences in antibody titers were found in the Gardasil group. Mild injection site reactions were more common in the Cervarix group than in the Gardasil group (91.1% vs 69.6%; P = .02). No serious adverse events occurred.Conclusions. Both vaccines were immunogenic and well tolerated. Compared with Gardasil, Cervarix induced superior vaccine responses among HIV-infected women, whereas in HIV-infected men the difference in immunogenicity was less pronounced.Clinical Trials Registration NCT01386164.
- Subjects
HIV-positive persons; CLINICAL trials; BLIND experiment; GARDASIL (Drug); HUMAN papillomavirus vaccines; SEROLOGY; VACCINATION; THERAPEUTICS
- Publication
Journal of Infectious Diseases, 2014, Vol 209, Issue 8, p1165
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jit657