Long-term study of a quadrivalent human papillomavirus vaccine

Daron 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 journalArticlepeer-review

94 Scopus citations


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
Issue number3
StatePublished - Sep 1 2014


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

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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