Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children

• Published in: Archives of disease in childhood 2006-11, Vol.91 (11), p.905-910
• Main Authors: Hofman, T, Cranswick, N, Kuna, P, Boznanski, A, Latos, T, Gold, M, Murrell, D F, Gebauer, K, Behre, U, Machura, E, Ólafsson, J, Szalai, Z
• Format: Article
• Language: English
• Subjects: Administration, Topical; Allergies; Antigens, CD - immunology; Atopic dermatitis; Biological and medical sciences; Care and treatment; Child; Child, Preschool; Children; Control Groups; Dermatitis; Dermatitis, Atopic - drug therapy; Dermatitis, Atopic - immunology; Diseases; Dosage and administration; Double-Blind Method; Female; Humans; Immune response; Immunity, Cellular - drug effects; Immunoglobulin Isotypes - immunology; Immunologic Memory - drug effects; Immunomodulators; Immunosuppressive Agents - adverse effects; Male; Medical sciences; Meningococcal Infections - immunology; Meningococcal Infections - prevention & control; Meningococcal Vaccines - immunology; Miscellaneous; Neisseria meningitidis; Neisseria meningitidis, Serogroup C; Original; Patients; Pediatric diseases; Pharmaceutical industry; Pharmacology. Drug treatments; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; SAE; Sample Size; SBA; Scientific Concepts; serious adverse event; serum bactericidal antibody; Studies; TAC-O; Tacrolimus; Tacrolimus - adverse effects; tacrolimus ointment; Vaccines
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/adc.2006.094276

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.