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4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years

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  • Daron G Ferris
  • Rudiwilai Samakoses
  • Stanley L Block
  • Eduardo Lazcano-Ponce
  • Jaime Alberto Restrepo
  • Jesper Mehlsen
  • Archana Chatterjee
  • Ole-Erik Iversen
  • Amita Joshi
  • Jian-Li Chu
  • Andrea Likos Krick
  • Alfred Saah
  • Rituparna Das
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OBJECTIVES: We describe the final 10-year data for the long-term follow-up study of the 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents.

METHODS: In the base study (V501-018), 1661 sexually inactive boys and girls received the 4vHPV vaccine (early vaccination group [EVG], managed for 9.9 years) or a placebo at day 1, month 2, and month 6. Thereafter, at month 30, the placebo group (catch-up vaccination group [CVG], managed for 7.4 years) received the 4vHPV vaccine by using the same dosing schedule. Long-term anti-HPV type 6, 11, 16, and 18 immune responses were assessed. Effectiveness was estimated by calculating the incidence rate of the primary endpoints (HPV types 6, 11, 16, and 18-related disease or persistent infection).

RESULTS: For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18-related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years.

CONCLUSIONS: A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure.

Original languageEnglish
JournalPediatrics
Volume140
Issue number6
ISSN0031-4005
DOIs
Publication statusPublished - Dec 2017

    Research areas

  • Adolescent, Child, Female, Follow-Up Studies, Humans, Male, Papillomaviridae, Papillomavirus Infections, Papillomavirus Vaccines, Journal Article

ID: 52225214