title: Safety of influenza vaccine in heart transplant recipients.
abstract: BACKGROUND
  Influenza vaccine is recommended for heart transplant recipients, but its administration is often deferred because of anecdotal reports of rejection associated with the vaccine. We evaluated the safety of influenza vaccine in a group of stable heart transplant recipients over a 2-year period.
  
  
  METHODS
  During the 1993 to 1994 influenza season, stable heart transplant recipients who had undergone transplantation a minimum of 1 year before study entry were randomized to vaccination with a single dose of influenza vaccine versus no vaccination. Routine endomyocardial biopsies and postvaccination influenza serologic studies were performed between 2 and 6 weeks after enrollment/immunization. During the 1994 to 1995 season, patients were given 2 doses of influenza vaccine, separated by 3 weeks; endomyocardial biopsies and serologic studies were performed between 2 and 6 weeks after the second immunization or enrollment (if control subject). Biopsy results were evaluated with respect to vaccine response, immunosuppressive regimens, and patient demographics.
  
  
  RESULTS
  Eighteen patients were enrolled in the single vaccine trial and 10 in the booster vaccine trial. Four of 14 vaccine recipients had biopsy specimens consistent with International Society for Heart and Lung Transplantation grades 2 to 3A as compared with 1 of 14 control subjects (grade 2) (p = .326). All episodes of rejection in the vaccine recipients were asymptomatic and responded to a single course of treatment. Rejection was unrelated to the time from transplantation, doses of immunosuppression, age, or number of doses of or response to vaccine.
  
  
  CONCLUSIONS
  Influenza vaccine can be safely administered to most heart transplant recipients but may be associated with low-level histologic rejection.
authors.affiliation: MCP Hahnemann School of Medicine, Allegheny University of the Health Sciences, Philadelphia, PA, USA. blumberge@auhs.edu
authors.forename: E A
authors.initials: EA
authors.lastname: Blumberg
authors.forename: J
authors.initials: J
authors.lastname: Fitzpatrick
authors.forename: P C
authors.initials: PC
authors.lastname: Stutman
authors.forename: F G
authors.initials: FG
authors.lastname: Hayden
authors.forename: S C
authors.initials: SC
authors.lastname: Brozena
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000032:analysis; D001706:Biopsy; D004699:Endocardium / Q000473:pathology; D005260:Female; D006084:Graft Rejection / Q000209:etiology; D016027:Heart Transplantation; D006801:Humans; D007117:Immunization, Secondary; D007252:Influenza Vaccines / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009975:Orthomyxoviridae / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines