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

Daron Gale 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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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 1 2017

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Papillomavirus Vaccines
Human papillomavirus 11
Human papillomavirus 6
Vaccination
Infection
Placebos
Human papillomavirus 16
Appointments and Schedules
Incidence
Population

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., ... 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

4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. / Ferris, Daron Gale; Samakoses, Rudiwilai; Block, Stanley L.; Lazcano-Ponce, Eduardo; Restrepo, Jaime Alberto; Mehlsen, Jesper; Chatterjee, Archana; Iversen, Ole Erik; Joshi, Amita; Chu, Jian Li; Krick, Andrea Likos; Saah, Alfred; Das, Rituparna.

In: Pediatrics, Vol. 140, No. 6, e20163947, 01.12.2017.

Research output: Contribution to journalArticle

Ferris, DG, Samakoses, R, Block, SL, Lazcano-Ponce, E, Restrepo, JA, Mehlsen, J, Chatterjee, A, Iversen, OE, Joshi, A, Chu, JL, Krick, AL, Saah, A & Das, R 2017, '4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years', Pediatrics, vol. 140, no. 6, e20163947. https://doi.org/10.1542/peds.2016-3947
Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J et al. 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. Pediatrics. 2017 Dec 1;140(6). e20163947. https://doi.org/10.1542/peds.2016-3947
Ferris, Daron Gale ; Samakoses, Rudiwilai ; Block, Stanley L. ; Lazcano-Ponce, Eduardo ; Restrepo, Jaime Alberto ; Mehlsen, Jesper ; Chatterjee, Archana ; Iversen, Ole Erik ; Joshi, Amita ; Chu, Jian Li ; Krick, Andrea Likos ; Saah, Alfred ; Das, Rituparna. / 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. In: Pediatrics. 2017 ; Vol. 140, No. 6.
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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.",
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AU - Ferris, Daron Gale

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AU - Lazcano-Ponce, Eduardo

AU - Restrepo, Jaime Alberto

AU - Mehlsen, Jesper

AU - Chatterjee, Archana

AU - Iversen, Ole Erik

AU - Joshi, Amita

AU - Chu, Jian Li

AU - Krick, Andrea Likos

AU - Saah, Alfred

AU - Das, Rituparna

PY - 2017/12/1

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N2 - 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.

AB - 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.

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