4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years

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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18 Scopus citations

Abstract

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 (US)
Article numbere20163947
JournalPediatrics
Volume140
Issue number6
DOIs
StatePublished - Dec 2017

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Ferris, D. G., Samakoses, R., Block, S. L., Lazcano-Ponce, E., Restrepo, J. A., Mehlsen, J., Chatterjee, A., Iversen, O. E., Joshi, A., Chu, J. L., Krick, A. L., Saah, A., & Das, R. (2017). 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. Pediatrics, 140(6), [e20163947]. https://doi.org/10.1542/peds.2016-3947