Nielsen, Lars Toft5; Storgaard, Merete5; Müller, Martin3; Sehr, Peter3; Bonde, Jesper4; Tolstrup, Martin5; Østergaard, Lars Jørgen5; Søgaard, Ole S5
1 Department of Clinical Medicine - Department of Infectious Diseases, Department of Clinical Medicine, Health, Aarhus University2 Department of Bioscience - Arctic Research Centre, Brendstrupgårdsvej, Department of Bioscience, Science and Technology, Aarhus University3 unknown4 Department of Molecular Biology, Faculty of Science, Aarhus University, Aarhus University5 Department of Clinical Medicine - Department of Infectious Diseases, Department of Clinical Medicine, Health, Aarhus University
A Randomized, Double-Blind Clinical Trial
Objectives. To compare the immunogenicity and reactogenicity of Cervarix(®) or Gardasil(®) Human Papillomavirus (HPV) vaccines in HIV-infected adults.Methods. A double-blind, controlled trial randomizing HIV-positive adults to receive three 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 (PBNA). 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 gender-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.
Journal of Infectious Diseases, 2013, Vol 209, Issue 8, p. 1165-1173