What is the role of the 9-valent HPV vaccine (Gardasil 9 [9vHPV]) in the prevention of human papillomavirus (HPV) infection?

Updated: Feb 20, 2020
  • Author: Peter A Gearhart, MD; Chief Editor: Pranatharthi Haran Chandrasekar, MBBS, MD  more...
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Initially approved in 2014, the 9-valent HPV vaccine (Gardasil 9 [9vHPV]) is the only available vaccine in the United States shown to decrease the risk of certain cancers and precancerous lesions in males and females aged 9-45 years. 9vHPV vaccine covers HPV subtypes 6, 11, 16, 18, 31, 33, 45, 52, and 58. Cervarix (2vHPV) and Gardasil (4vHPV) were discontinued in the United States in October 2016. Children and adolescents aged 15 years and younger need two, not three, doses of the 9vHPV vaccine; this ACIP recommendation stems from the vaccine’s enhanced immunogenicity in preteens and adolescents aged 9-14 years. The schedule for older adolescents and young adults aged 15-45 years is 2-3 inoculations (depending on immunization history) within 6 months.

The World Health Organization (WHO) recommends vaccination against HPV subtypes 16 and 18. [42]

Approval for adults aged up to 45 years was based on a study of approximately 3200 women aged 27-45 years monitored for an average of 3.5 years. 9vHPV vaccine was 88% effective in preventing the combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. [90, 91] For adults aged 27-45 years, the need for vaccination is based on shared decision making between patient and clinician. [92]

Effectiveness of 9vHPV in men aged 27-45 years is inferred from the data described above in women, as well as efficacy data in younger men (aged 16-26 years) and immunogenicity data from a clinical trial in which 150 men aged 27-45 years received a 3-dose regimen over 6 months. [91]

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