Tacrolimus Ointment does not Affect the Immediate Response to Vaccination, the Generation of Immune Memory, or Humoral and Cell-Mediated Immunity in Children

Teresa Hofman ^1*, Noel Cranswick ², Poitr Kuna ³, Andrzej Boznanski ⁴, Tadeusz Latos ⁵, Michael Gold ⁶, Dedee Murell ⁷, Kurt Gebauer ⁸, Ulrich Behre ⁹, Edyta Machura ¹⁰, Jón &Oacutelafsson ¹¹ and Zsuzsanna Szalai ¹²

¹ Allergy Centre, Poznan, Poland
² Paediatric Pharmacology Research Unit, Royal Children’s Hospital, Parkville,, Australia
³ Division of Pneumonology and Allergy, Barlicki University Hospital, Medical University of Lodz, Poland
⁴ I Katedra Pediatrii Klinika Alergologii I Kardiologii, Wroclawska Akademia Medyczna, Wroclaw, Poland
⁵ Centrum Pulmonologii Dzieciecej, Karpacz, Poland
⁶ Department of Paediatrics, Women's and Children's Hospital, North Adelaide, Australia
⁷ Dermatology Department, St. George Hospital, Kogarah, Australia
⁸ Fremantle Dermatology Clinic, Fremantle, Australia
⁹ Hauptstr. 240, 77694 Kehl, Germany
¹⁰ Oddzial Pulmonologii I Alergologii, Slaskie Centrum Pediatrii, Zabrze, Poland
¹¹ Hudlaeknastödin, Kopavogur, Iceland
¹² Department of Dermatology, Heim Pal Children's Hospital, Budapest, Hungary

^* To whom correspondence should be addressed. E-mail: claire.foster{at}eu.astellas.com.

Accepted 5 June 2006

Abstract

Background: Atopic dermatitis (AD) is a chronic disease that often requires long-term treatment. There is concern that the prolonged application of topical immunomodulators may cause systemic immunosuppression.

Aims: In a seven-month, multicentre, randomized, 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-severe AD applying either 0.03% tacrolimus ointment (TAC-O; N=121) or a hydrocortisone ointment regimen (HC-O; N=111).

Methods: TAC-O was applied twice daily (bid) for three weeks; thereafter daily until clearance. The hydrocortisone regimen consisting of 1% hydrocortisone acetate (HA) for the head and neck, and 0.1% hydrocortisone butyrate ointment for the trunk and limbs was applied bid for two weeks; thereafter only HA was applied bid to all affected areas. At Week 1, patients were vaccinated with a protein-conjugate vaccine against meningococcal serogroup C, and challenged at Month 6 with a low dose of meningo polysaccharide vaccine. The control group (44 children with no AD) received only the primary vaccination and challenge dose. Assessments were made at baseline, Weeks 1 and 5, and Months 6 and 7. The primary endpoint 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% [CI normal approx: 97.3, 100], 99.1% [94.8, 100], and 97.7% [93.3, 100] in the TAC-O, HC-O, and control groups, respectively. Geometric mean titres for SBA immediately increased following primary vaccination (Week 5: 4489.2, 5562.4, and 5026.9 for the TAC-O, HC-O, and control groups, respectively), decreased with time (Month 6: 1024.0, 965.2, and 1698.1, respectively) and increased again following challenge (Month 7: 3273.2, 3756.0, and 3511.3, respectively).

Conclusions: The immune response to a vaccination against meningococcal serogroup C with a protein- conjugate vaccine in children with moderate to severe AD applying either 0.03% TAC-O or HC is equivalent. Ointment application does not adversely affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in childhood.

Keywords: atopic, children, dermatitiis, tacrolimus, vaccination

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