Long-term study of a quadrivalent human papillomavirus vaccine

Daron Gale Ferris, Rudiwilai Samakoses, Stan L. Block, Eduardo Lazcano-Ponce, Jaime Alberto Restrepo, Keith S. Reisinger, Jesper Mehlsen, Archana Chatterjee, Ole Erik Iversen, Heather L. Sings, Qiong Shou, Timothy A. Sausser, Alfred Saah

Research output: Contribution to journalArticle

70 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)e657-e665
JournalPediatrics
Volume134
Issue number3
DOIs
StatePublished - Sep 1 2014

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Papillomavirus Vaccines
Vaccines
Placebos
Sexual Partners
Infection
Vaccination
Safety
Antibodies

Keywords

  • Adolescents
  • Anogenital cancer
  • Effectiveness
  • Genital warts
  • Immunogenicity
  • Immunogenicity
  • Quadrivalent HPV vaccine
  • Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Ferris, D. G., Samakoses, R., Block, S. L., Lazcano-Ponce, E., Alberto Restrepo, J., Reisinger, K. S., ... Saah, A. (2014). Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics, 134(3), e657-e665. https://doi.org/10.1542/peds.2013-4144

Long-term study of a quadrivalent human papillomavirus vaccine. / Ferris, Daron Gale; Samakoses, Rudiwilai; Block, Stan L.; Lazcano-Ponce, Eduardo; Alberto Restrepo, Jaime; Reisinger, Keith S.; Mehlsen, Jesper; Chatterjee, Archana; Iversen, Ole Erik; Sings, Heather L.; Shou, Qiong; Sausser, Timothy A.; Saah, Alfred.

In: Pediatrics, Vol. 134, No. 3, 01.09.2014, p. e657-e665.

Research output: Contribution to journalArticle

Ferris, DG, Samakoses, R, Block, SL, Lazcano-Ponce, E, Alberto Restrepo, J, Reisinger, KS, Mehlsen, J, Chatterjee, A, Iversen, OE, Sings, HL, Shou, Q, Sausser, TA & Saah, A 2014, 'Long-term study of a quadrivalent human papillomavirus vaccine', Pediatrics, vol. 134, no. 3, pp. e657-e665. https://doi.org/10.1542/peds.2013-4144
Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Alberto Restrepo J, Reisinger KS et al. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014 Sep 1;134(3):e657-e665. https://doi.org/10.1542/peds.2013-4144
Ferris, Daron Gale ; Samakoses, Rudiwilai ; Block, Stan L. ; Lazcano-Ponce, Eduardo ; Alberto Restrepo, Jaime ; Reisinger, Keith S. ; Mehlsen, Jesper ; Chatterjee, Archana ; Iversen, Ole Erik ; Sings, Heather L. ; Shou, Qiong ; Sausser, Timothy A. ; Saah, Alfred. / Long-term study of a quadrivalent human papillomavirus vaccine. In: Pediatrics. 2014 ; Vol. 134, No. 3. pp. e657-e665.
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AU - Alberto Restrepo, Jaime

AU - Reisinger, Keith S.

AU - Mehlsen, Jesper

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AU - Iversen, Ole Erik

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