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Pediatrics. 2014 Sep;134(3):e657-65. doi: 10.1542/peds.2013-4144. Epub 2014 Aug 18.

Long-term study of a quadrivalent human papillomavirus vaccine.

Author information

1
Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia; dferris@gru.edu.
2
Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand;
3
Kentucky Pediatric and Adult Research, Inc, Bardstown, Kentucky;
4
Center for Research in Population Health, National Institute of Public Health, Cuernavaca Morelos, Mexico;
5
Clinical Research Center, Medellín, Colombia;
6
Primary Physicians Research, Pittsburgh, Pennsylvania;
7
Coordinating Research Centre, Frederiksberg Hospital, Frederiksberg, Denmark;
8
Department of Pediatrics, University of South Dakota Sanford School of Medicine, Sanford Children's Specialty Clinics, Sioux Falls, South Dakota;
9
Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; and.
10
Merck & Co., Inc, Whitehouse Station, New Jersey.

Abstract

BACKGROUND:

We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine.

METHODS:

Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6. At month 30, the placebo group (n = 482) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96. Subjects ≥ 16 years were eligible for effectiveness evaluations. The primary objective was to evaluate the long-term anti-HPV6/11/16/18 serological levels. The secondary objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease.

RESULTS:

For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6/11/16/18-related disease or persistent infection of ≥ 12 months' duration. Acquisition of new sexual partners (among those ≥ 16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥ 1 of the 4 HPV types to those vaccinated at day 1 (mean age 12 years; 1.9% [9 of 474] vs 1.7% [20 of 1157]); however, 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types, indicating previous HPV exposure. No new significant serious adverse events were observed for 8 years postvaccination in both genders.

CONCLUSIONS:

When administered to adolescents, the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years.

KEYWORDS:

adolescents; anogenital cancer; effectiveness; genital warts; immunogenicity; quadrivalent HPV vaccine; safety

PMID:
25136050
DOI:
10.1542/peds.2013-4144
[Indexed for MEDLINE]
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