title: Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children.
abstract: BACKGROUND
  Concern exists that the prolonged application of immunomodulators to treat atopic dermatitis may cause systemic immunosuppression.
  
  
  OBJECTIVE
  In a 7-month, multicentre, randomised, controlled trial, we investigated the equivalence of response to vaccination against meningococcal serogroup C disease with a protein-conjugate vaccine in children (2-11 years) with moderate to severe atopic dermatitis, by applying either 0.03% tacrolimus ointment (TAC-O; n = 121[corrected]) or a hydrocortisone ointment regimen (HC-O; n = 111).
  
  
  METHODS
  TAC-O was applied twice daily (bid) for 3 weeks, and thereafter daily until clearance. 1% hydrocortisone acetate (HA) for head/neck and 0.1% hydrocortisone butyrate ointment for trunk/limbs was applied bid for 2 weeks; thereafter HA was applied bid to all affected areas. At week 1, patients were vaccinated with protein-conjugate vaccine against meningococcal serogroup C, and challenged at month 6 with low dose meningococcal polysaccharide vaccine. The control group (44 non-atopic dermatitis children) received the primary vaccination and challenge dose. Assessments were made at baseline, weeks 1 and 5, and months 6 and 7. The primary end point was the percentage of patients with a serum bactericidal antibody (SBA) titre > or = 8 at the week 5 visit.
  
  
  RESULTS
  The response rate (patients with SBA titre > or = 8) was 97.5% (confidence interval (CI) approximately 97.3 to 100), 99.1% (94.8 to 100) and 97.7% (93.3 to 100) in the TAC-O, HC-O and control groups, respectively.
  
  
  CONCLUSIONS
  The immune response to vaccination against meningococcal serogroup C in children with atopic dermatitis applying either 0.03% TAC-O or HC is equivalent. Ointment application does not affect the immediate response to vaccination, generation of immune memory or humoral and cell-mediated immunity.
authors.affiliation: Allergy Centre, Poznan, Poland. T.Hofman@interia.pl
authors.forename: T
authors.initials: T
authors.lastname: Hofman
authors.forename: N
authors.initials: N
authors.lastname: Cranswick
authors.forename: P
authors.initials: P
authors.lastname: Kuna
authors.forename: A
authors.initials: A
authors.lastname: Boznanski
authors.forename: T
authors.initials: T
authors.lastname: Latos
authors.forename: M
authors.initials: M
authors.lastname: Gold
authors.forename: D F
authors.initials: DF
authors.lastname: Murrell
authors.forename: K
authors.initials: K
authors.lastname: Gebauer
authors.forename: U
authors.initials: U
authors.lastname: Behre
authors.forename: E
authors.initials: E
authors.lastname: Machura
authors.forename: J
authors.initials: J
authors.lastname: Olafsson
authors.forename: Z
authors.initials: Z
authors.lastname: Szalai
mesh_terms: D000287:Administration, Topical; D015703:Antigens, CD / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects; D007132:Immunoglobulin Isotypes / Q000276:immunology; D007156:Immunologic Memory / Q000187:drug effects; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology* / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C; D016559:Tacrolimus / Q000009:adverse effects*
chemical_list: D015703:Antigens, CD; D007132:Immunoglobulin Isotypes; D007166:Immunosuppressive Agents; D022401:Meningococcal Vaccines; C410218:serogroup C meningococcal conjugate vaccine; D016559:Tacrolimus