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Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children
  1. T Hofman1,
  2. N Cranswick2,
  3. P Kuna3,
  4. A Boznanski4,
  5. T Latos5,
  6. M Gold6,
  7. D F Murrell7,
  8. K Gebauer8,
  9. U Behre9,
  10. E Machura10,
  11. J Ólafsson11,
  12. Z Szalai12,
  13. on behalf of the International Tacrolimus Ointment Study Group*
  1. 1Allergy Centre, Poznan, Poland
  2. 2Paediatric Pharmacology Research Unit, Royal Children’s Hospital, Parkville, Victoria, Australia
  3. 3Division of Pneumonology and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
  4. 4I Katedra Pediatrii Klinika Alergologii I Kardiologii, Wroclawska Akademia Medyczna, Wroclaw, Poland
  5. 5Centrum Pulmonologii Dzieciecej, Karpacz, Poland
  6. 6Department of Paediatrics, Women’s and Children’s Hospital, North Adelaide, Adelaide, Australia
  7. 7Dermatology Department, St George Hospital, University of New South Wales, Sydney, New South Wales, Australia
  8. 8Fremantle Dermatology Clinic, Fremantle, Western Australia, Australia
  9. 9Hauptstr 240, Kehl, Germany
  10. 10Oddzial Pulmonologii I Alergologii, Slaskie Centrum Pediatrii, Zabrze, Poland
  11. 11Hudlaeknastödin, Kopavogur, Iceland
  12. 12Department of Dermatology, Heim Pal Children’s Hospital, Budapest, Hungary
  1. Correspondence to:
    T Hofman
    Allergy Centre, Boguslawskiego 16a, 60-214 Poznan, Poland; T.Hofman{at}


Background: Concern exists that the prolonged application of immunomodulators to treat atopic dermatitis may cause systemic immunosuppression.

Aims: 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 = 21) 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 dermatatits 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 ⩾8 at the week 5 visit.

Results: The response rate (patients with SBA titre ⩾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.

  • SAE, serious adverse event
  • SBA, serum bactericidal antibody
  • TAC-O, tacrolimus ointment

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  • * Additional members of the International Tacrolimus Ointment Study Group: E Bernatowska, A Cooper, H Costa, A Dobozy, P Foley, M Freeman, M Gelb, F Harangi, J Hunyadi, A Jankowski, A Kaszuba, U Kircher, K Kirsten, R Kurzawa, K-E Mai, A Milanowski, M-A Morren, J Peake, J Pietrzyk, L Scerri, S Shumack, V C Sousa, L Spelman, I Stelmach, G Wasik.

  • Published Online First 23 June 2006

  • Competing interests: We received study grants from Astellas Pharma to carry out this study.

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