Adverse events and association with age, sex and immunological parameters of Q fever vaccination in patients at risk for chronic Q fever in the Netherlands 2011

Teske Schoffelen, Albert Wong, Hans C Rümke, Mihai G Netea, Aura Timen, Marcel van Deuren, Patricia E Vermeer-de Bondt

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

BACKGROUND: Following a large Q fever outbreak in the Netherlands, patients at risk for chronic Q fever received a whole-cell Q fever vaccine. Sensitized people were excluded based on pre-vaccination screening with skin test (ST) and serology. An investigational IFN-γ-production assay was added. No previous experience existed for Q fever vaccination in this patient risk-group with predefined cardiac valvular anomalies or aortic aneurysm/prosthesis and many co-morbidities. We studied the adverse events (AE) and their association with patient characteristics and immunological parameters.

METHODS: AE registration covered the week after skin test and 90 days following vaccination, with the use of diaries, interviews and spontaneous reports. Serious (S)AE were assessed immediately to ensure safety. We coded AE according to reported severity. Univariate and multivariate analysis addressed associations.

RESULTS: Pre-vaccination screening led to exclusion of 182 patients with positive serology and 207 patients with positive skin test-reading. The skin test did not lead to any causally related SAE. Subsequent vaccination of 1370 patients did not reveal unexpected AE; however, 80% of vaccinees reported local AE (in 26% of these pronounced or extensive). The two causally related SAE (0.1%) both concerned a persistent subcutaneous injection site mass. AE were more frequent in women, younger patients, and those without immunosuppressive co-morbidity/medication. The occurrence of local AE after skin test was associated with pre-vaccination positive serology and high IFN-γ production. This was also true for local AE following vaccination, with a strong association with local AE after skin test as well. The proportion of vaccinees with positive serology and positive IFN-γ values 6 months after vaccination was higher in those with local AE after skin test or after vaccination (non-significant, probably due to small numbers).

CONCLUSION: Q fever vaccination was safe but reactogenic in this high-risk patient-group. Rates of local AE were higher in women, younger age groups and in those with positive immunological parameters. Vaccinees with local AE after skin test or after vaccination appear to have more pronounced post-vaccination immune responses.

Original languageEnglish
Pages (from-to)6622-30
Number of pages9
JournalVaccine
Volume32
Issue number49
DOIs
Publication statusPublished - 20 Nov 2014
Externally publishedYes

Keywords

  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Biomarkers
  • Drug-Related Side Effects and Adverse Reactions/epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Netherlands/epidemiology
  • Q Fever/immunology
  • Risk Factors
  • Sex Factors
  • Vaccination/adverse effects
  • Viral Vaccines/administration & dosage
  • Young Adult

Fingerprint Dive into the research topics of 'Adverse events and association with age, sex and immunological parameters of Q fever vaccination in patients at risk for chronic Q fever in the Netherlands 2011'. Together they form a unique fingerprint.

Cite this