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

• Published in: The Journal of infectious diseases 2014-04, Vol.209 (8), p.1165-1173
• Main Authors: Toft, Lars, Storgaard, Merete, Müller, Martin, Sehr, Peter, Bonde, Jesper, Tolstrup, Martin, Østergaard, Lars, Søgaard, Ole S.
• Format: Article
• Language: English
• Subjects: Adult; Antibodies; Antibodies, Neutralizing - blood; Antibodies, Viral - blood; Applied microbiology; Biological and medical sciences; Cancer; Denmark; DNA; DNA, Viral - analysis; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Highly active antiretroviral therapy; HIV; HIV infections; HIV Infections - immunology; HIV Infections - virology; HIV/AIDS; Human papillomavirus 16 - genetics; Human papillomavirus 16 - immunology; Human papillomavirus 18 - genetics; Human papillomavirus 18 - immunology; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Human viral diseases; Humans; Immune response; Infectious diseases; Injection sites; Male; Medical sciences; Microbiology; Middle Aged; Miscellaneous; Papillomavirus Infections - immunology; Papillomavirus Infections - prevention & control; Papillomavirus Infections - virology; Papillomavirus vaccines; Papillomavirus Vaccines - administration & dosage; Uterine Cervical Neoplasms - immunology; Uterine Cervical Neoplasms - prevention & control; Uterine Cervical Neoplasms - virology; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Virology
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jit657

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.