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
StatePublished - Jun 14 2017

Fingerprint

Dengue Vaccines
dengue
Immunity
immunity
vaccines
Safety
Dengue
Age Groups
Antibody-Dependent Enhancement
Hospitalization
cumulative risk
Vaccines
protective effect
antibodies

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

Dengue vaccine safety signal : Immune enhancement, waning immunity, or chance occurrence? / Gessner, Bradford D.; Halsey, Neal A.

In: Vaccine, Vol. 35, No. 27, 14.06.2017, p. 3452-3456.

Research output: Contribution to journalArticle

@article{888b1d423a0e4f9abc9c4dafa4f84aab,
title = "Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?",
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.",
keywords = "Adverse events following immunization, Clinical trial, Dengue, Immunization, Safety, Vaccine",
author = "Gessner, {Bradford D.} and Halsey, {Neal A}",
year = "2017",
month = "6",
day = "14",
doi = "10.1016/j.vaccine.2017.05.003",
language = "English (US)",
volume = "35",
pages = "3452--3456",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "27",

}

TY - JOUR

T1 - Dengue vaccine safety signal

T2 - Immune enhancement, waning immunity, or chance occurrence?

AU - Gessner, Bradford D.

AU - Halsey, Neal A

PY - 2017/6/14

Y1 - 2017/6/14

N2 - 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.

AB - 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.

KW - Adverse events following immunization

KW - Clinical trial

KW - Dengue

KW - Immunization

KW - Safety

KW - Vaccine

UR - http://www.scopus.com/inward/record.url?scp=85019354473&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019354473&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2017.05.003

DO - 10.1016/j.vaccine.2017.05.003

M3 - Article

C2 - 28528764

AN - SCOPUS:85019354473

VL - 35

SP - 3452

EP - 3456

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 27

ER -