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Pediatrics. 2017 Dec;140(6). pii: e20163947. doi: 10.1542/peds.2016-3947.

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

Author information

1
Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia.
2
Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
3
Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
4
Centro de Investigación en Salud Poblacional, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, Mexico.
5
Fundación Centro de Investigación Clínica, Medellín, Colombia.
6
Coordinating Research Centre, Frederiksberg Hospital, Frederiksberg, Denmark.
7
Department of Pediatrics, Sanford School of Medicine, University of South Dakota and Sanford Children's Specialty Clinics, Sioux Falls, South Dakota.
8
Department of Clinical Science, University of Bergen and Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway; and.
9
Merck & Company Inc, Kenilworth, New Jersey.
10
Merck & Company Inc, Kenilworth, New Jersey rituparna.das@merck.com.

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.

PMID:
29167376
DOI:
10.1542/peds.2016-3947
[Indexed for MEDLINE]
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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Ferris has received grant support from Merck & Company Inc (Kenilworth, NJ) through his institution and personal fees for consultancy and advisory boards for Merck & Company; Drs Block and Lazcano-Ponce have received research grants from and are members of a speaker’s bureau for Merck & Company and have served as paid expert witnesses and consultants for Merck & Company; Dr Mehlsen has received funding from Merck & Company to conduct human papillomavirus–vaccine clinical trials; Dr Chatterjee has received funding from Merck & Company and GlaxoSmithKline to conduct human papillomavirus–vaccine clinical trials and served on a speaker’s bureau for Merck & Company; Dr Iversen has received compensation from Merck & Company to conduct vaccine clinical trials and for scientific advisory board fees; Drs Joshi, Chu, Krick-Likos, Saah, and Das are employees of Merck Sharp & Dohme Corporation, a subsidiary of Merck & Company and may hold stock options; the other authors have indicated they have no potential conflicts of interest to disclose.

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