Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?

Bradford D. Gessner, Neal A Halsey

Research output: Contribution to journalArticle

Abstract

A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2–5 years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs. control children age 2–5 years at the end of year 5 and lower for vaccinated vs. control children among older age groups; (d) the protective effect of vaccine against hospitalization decreased from years 1–2 to years 3–5 of follow-up for all age groups and regions.

Original languageEnglish (US)
Pages (from-to)3452-3456
Number of pages5
JournalVaccine
Volume35
Issue number27
DOIs
Publication statusPublished - Jun 14 2017

    Fingerprint

Keywords

  • Adverse events following immunization
  • Clinical trial
  • Dengue
  • Immunization
  • Safety
  • Vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this