title: Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series.
abstract: OBJECTIVE
  To assess the risk of solid organ transplant (SOT) rejection after vaccination with the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine Pandemrix.
  
  
  METHODS
  Self-controlled case series (SCCS) in the UK Clinical Practice Research Datalink (CPRD) and its linked component of the Hospital Episodes Statistics (HES) inpatient database. Analyses were conducted using the SCCS method for censored, perturbed or curtailed post-event exposure.
  
  
  METHODS
  Of the 184 transplant recipients having experienced at least one SOT rejection (liver, kidney, lung, heart or pancreas) during the study period from 1 October 2009 to 31 October 2010, 91 participants were included in the main analysis, of which 71 had been exposed to Pandemrix.
  
  
  METHODS
  Occurrence of SOT rejection during risk (30 and 60 days after any Pandemrix dose) and control periods. Covariates in the CPRD included time since transplantation, seasonal influenza vaccination, bacterial and viral infections, previous SOT rejections and malignancies.
  
  
  RESULTS
  The relative incidence (RI) of rejection of any one of the five transplanted organs, adjusted for time since transplantation, was 1.05 (95% CI 0.52 to 2.14) and 0.80 (95% CI 0.42 to 1.50) within 30 and 60 days after vaccination, respectively. Similar estimates were observed for rejection of a kidney only, the most commonly transplanted organ (RI within 30 days after vaccination: 0.85 (95% CI 0.38 to 1.90)). Across various models and sensitivity analyses, RI estimates remained stable and within a consistent range around 1.0.
  
  
  CONCLUSIONS
  These results suggest a reassuring safety profile for Pandemrix with regard to the risk of rejection in SOT recipients in England and contribute to inform the benefit-risk of AS03-adjuvanted pandemic influenza vaccines in transplanted patients in the event of future pandemics.
  
  
  BACKGROUND
  NCT01715792.
authors.affiliation: Global Epidemiology, GSK Vaccines, Wavre, Belgium.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cohet
authors.affiliation: Global Epidemiology, GSK Vaccines, Wavre, Belgium.
authors.forename: François
authors.initials: F
authors.lastname: Haguinet
authors.affiliation: Business & Decision Life Sciences, Brussels, Belgium (on behalf of GSK Vaccines).
authors.forename: Gaël
authors.initials: G
authors.lastname: Dos Santos
authors.affiliation: Department of R&D, GSK, Uxbridge, Middlesex, UK.
authors.forename: Dave
authors.initials: D
authors.lastname: Webb
authors.affiliation: Department of R&D, GSK, Uxbridge, Middlesex, UK.
authors.forename: John
authors.initials: J
authors.lastname: Logie
authors.affiliation: Global Epidemiology, GSK Vaccines, Wavre, Belgium.
authors.forename: Germano
authors.initials: G
authors.lastname: Lc Ferreira
authors.affiliation: Global Epidemiology, GSK Vaccines, Wavre, Belgium.
authors.forename: Dominique
authors.initials: D
authors.lastname: Rosillon
authors.affiliation: Global Epidemiology, GSK Vaccines, Wavre, Belgium.
authors.forename: Vivek
authors.initials: V
authors.lastname: Shinde
mesh_terms: D006084:Graft Rejection; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000517:prevention & control*; D012189:Retrospective Studies; D018570:Risk Assessment; D013997:Time Factors; D006113:United Kingdom; D014611:Vaccination / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; C556153:pandemrix
keywords: STATISTICS & RESEARCH METHODS; TRANSPLANT MEDICINE
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