Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (Types 6, 11, 16, and 18) L1 virus-like particle vaccine

Stan L. Block, Darron R. Brown, Archana Chatterjee, Michael A. Gold, Heather L. Sings, Anne Meibohm, Adrian Dana, Richard M. Haupt, Eliav Barr, Gretchen M. Tamms, Haiping Zhou, Keith S. Reisinger

Research output: Contribution to journalArticle

84 Scopus citations

Abstract

Background: We describe the safety of the human papillomavirus (HPV)-6/11/16/18 vaccine using updated clinical trial data (median follow-up time of 3.6 years) and summarize up to 3 years of post-licensure surveillance. Methods: In 5 clinical trials, 21,480 girls/women aged 9 to 26 years and boys aged 9 to 16 years received ≥1 dose of HPV-6/11/16/18 vaccine or placebo. All serious and nonserious adverse experiences (AEs) and new medical conditions were recorded for the entire study period(s). As of June 2009, >25 million doses of HPV-6/11/16/18 vaccine had been distributed in the United States with >50 million doses globally. Post-licensure safety as summarized by the Centers for Disease Control and Prevention using the United States Vaccine Adverse Event Reporting System database is also reported. Results: Eight subjects experienced a treatment-related serious AE (0.05% vaccine; 0.02% placebo). Of 18 deaths (0.1% vaccine; 0.1% placebo), all were considered unrelated to study treatment. New medical conditions which were potentially consistent with autoimmune phenomena were reported in 2.4% of both vaccine and placebo recipients. Pain, the most common injection-site AE, occurred more frequently with vaccine (81% vaccine; 75% placeboaluminum; 45% placebo-saline). No differences were seen in the incidence of the most common nonserious AEs-headache and pyrexia. The Vaccine Adverse Event Reporting System has received 14,072 reports for the HPV-6/11/16/18 vaccine since licensure, with only 7% being serious AEs, about half the average reported for licensed vaccines in general. Conclusions: HPV-6/11/16/18 vaccination was associated with more injection-site pain than placebo but similar incidences of systemic and serious AEs and new medical conditions potentially consistent with autoimmune phenomena. Based on review of post-licensure safety information, the benefits of vaccination to prevent the majority of genital tract precancers and cancers continue to far outweigh its risks.

Original languageEnglish (US)
Pages (from-to)95-101
Number of pages7
JournalPediatric Infectious Disease Journal
Volume29
Issue number2
DOIs
StatePublished - Feb 2010

Keywords

  • Cervical cancer
  • Genital warts
  • Human papillomavirus
  • Prophylactic vaccine
  • Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases
  • Microbiology (medical)

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  • Cite this

    Block, S. L., Brown, D. R., Chatterjee, A., Gold, M. A., Sings, H. L., Meibohm, A., Dana, A., Haupt, R. M., Barr, E., Tamms, G. M., Zhou, H., & Reisinger, K. S. (2010). Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (Types 6, 11, 16, and 18) L1 virus-like particle vaccine. Pediatric Infectious Disease Journal, 29(2), 95-101. https://doi.org/10.1097/INF.0b013e3181b77906