Quadrivalent HPV vaccine was effective in HPV-naive women, aged 24–45; FDA strengthens syncope warning.
The quadrivalent human papillomavirus (HPV) vaccine is recommended for girls and young women (age range, 9–26). Now, investigators have evaluated the efficacy and safety of the vaccine among older women (age range, 24–45) in Europe, the U.S., and Asia. In a manufacturer-sponsored trial, 3819 women were randomized to receive vaccine or placebo at study entry, at 2 months, and at 6 months. The primary endpoints were combined incidence of HPV-6, -11, -16, or -18 infections that lasted longer than 6 months and cervical and external genital disease caused by these HPV strains.
In a per-protocol analysis, 4 endpoints occurred among vaccinated women, and 41 occurred among women who received placebo, yielding a vaccine efficacy of 90.5% (95% confide…
Reviewing Author
DisclosuresConsultant/Advisory BoardAicuris; Bayer; GSK; Innovative Molecules; Merck; MAPP Biopharmaceutical (Safety Monitoring Committee)
RoyaltiesUpToDate
Grant/Research SupportNIH/National Institute of Allergy and Infectious Diseases; GSK; Moderna; Assembly Biomedical; Aicuris
Editorial BoardsSexually Transmitted Diseases; Sexually Transmitted Infections; Journal of Infectious Diseases
Leadership PositionsID Division Chiefs Community of Practice (At-Large Member)
DisclosuresConsultant/Advisory BoardAicuris; Bayer; GSK; Innovative Molecules; Merck; MAPP Biopharmaceutical (Safety Monitoring Committee)
RoyaltiesUpToDate
Grant/Research SupportNIH/National Institute of Allergy and Infectious Diseases; GSK; Moderna; Assembly Biomedical; Aicuris
Editorial BoardsSexually Transmitted Diseases; Sexually Transmitted Infections; Journal of Infectious Diseases
Leadership PositionsID Division Chiefs Community of Practice (At-Large Member)