Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/23297
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Type: Journal article
Title: Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children
Author: Hofman, T.
Cranswick, N.
Kuna, P.
Boznanski, A.
Latos, T.
Gold, M.
Murrell, D.
Gebauer, K.
Behre, U.
Machura, E.
Olafsson, J.
Szalai, Z.
Citation: Archives of Disease in Childhood, 2006; 91(11):905-910
Publisher: British Med Journal Publ Group
Issue Date: 2006
ISSN: 0003-9888
1468-2044
Statement of
Responsibility: 
T Hofman, N Cranswick, P Kuna, A Boznanski, T Latos, M Gold, D F Murrell, K Gebauer, U Behre, E Machura, J Ólafsson, Z Szalai
Abstract: 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.
Keywords: International Tacrolimus Ointment Study Group
Humans
Neisseria meningitidis, Serogroup C
Meningococcal Infections
Dermatitis, Atopic
Tacrolimus
Immunosuppressive Agents
Antigens, CD
Meningococcal Vaccines
Immunoglobulin Isotypes
Administration, Topical
Double-Blind Method
Immunity, Cellular
Immunologic Memory
Child
Child, Preschool
Female
Male
Rights: Copyright © 2006 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health
DOI: 10.1136/adc.2006.094276
Published version: http://dx.doi.org/10.1136/adc.2006.094276
Appears in Collections:Aurora harvest 2
Paediatrics publications

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