Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial

J Infect Dis. 2014 Apr 15;209(8):1165-73. doi: 10.1093/infdis/jit657. Epub 2013 Nov 23.


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.

Trial registration: NCT01386164.

Keywords: Cervarix; Gardasil; HIV; HPV vaccines; neutralizing antibodies; safety; serology.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Neutralizing / blood*
  • Antibodies, Viral / blood*
  • DNA, Viral / analysis
  • Denmark
  • Double-Blind Method
  • Female
  • HIV Infections / immunology*
  • HIV Infections / virology
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
  • Human papillomavirus 16 / genetics
  • Human papillomavirus 16 / immunology*
  • Human papillomavirus 18 / genetics
  • Human papillomavirus 18 / immunology*
  • Humans
  • Male
  • Middle Aged
  • Papillomavirus Infections / immunology
  • Papillomavirus Infections / prevention & control
  • Papillomavirus Infections / virology
  • Papillomavirus Vaccines / administration & dosage*
  • Uterine Cervical Neoplasms / immunology
  • Uterine Cervical Neoplasms / prevention & control
  • Uterine Cervical Neoplasms / virology


  • Antibodies, Neutralizing
  • Antibodies, Viral
  • DNA, Viral
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
  • Papillomavirus Vaccines
  • human papillomavirus vaccine, L1 type 16, 18

Associated data