Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children.
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.
Hofman
T
T
Allergy Centre, Poznan, Poland. T.Hofman@interia.pl
Cranswick
N
N
Kuna
P
P
Boznanski
A
A
Latos
T
T
Gold
M
M
Murrell
D F
DF
Gebauer
K
K
Behre
U
U
Machura
E
E
Olafsson
J
J
Szalai
Z
Z
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*
D015703:Antigens, CD; D007132:Immunoglobulin Isotypes; D007166:Immunosuppressive Agents; D022401:Meningococcal Vaccines; C410218:serogroup C meningococcal conjugate vaccine; D016559:Tacrolimus