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

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

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)905-910
Number of pages6
JournalArchives of Disease in Childhood
Volume91
Issue number11
DOIs
Publication statusPublished - Nov 2006

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hydrocortisone acetate
Tacrolimus
Ointments
Cellular Immunity
Vaccination
Atopic Dermatitis
Meningococcal Vaccines
Conjugate Vaccines
Control Groups
Antibodies
Immunologic Factors
Serum
Immunosuppression
Hydrocortisone
Proteins
Neck
Extremities
Randomized Controlled Trials
Head
Confidence Intervals

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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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. / 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.

In: Archives of Disease in Childhood, Vol. 91, No. 11, 11.2006, p. 905-910.

Research output: Contribution to journalArticle

Hofman, T, Cranswick, N, Kuna, P, Boznanski, A, Latos, T, Gold, M, Murrell, DF, Gebauer, K, Behre, U, Machura, E, Ólafsson, J & Szalai, Z 2006, 'Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children', Archives of Disease in Childhood, vol. 91, no. 11, pp. 905-910. https://doi.org/10.1136/adc.2006.094276
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. / Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. In: Archives of Disease in Childhood. 2006 ; Vol. 91, No. 11. pp. 905-910.
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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.",
author = "T. Hofman and N. Cranswick and P. Kuna and A. Boznanski and T. Latos and M. Gold and Murrell, {D. F.} and K. Gebauer and U. Behre and E. Machura and J. {\'O}lafsson and Z. Szalai",
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T1 - Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children

AU - Hofman, T.

AU - Cranswick, N.

AU - Kuna, P.

AU - Boznanski, A.

AU - Latos, T.

AU - Gold, M.

AU - Murrell, D. F.

AU - Gebauer, K.

AU - Behre, U.

AU - Machura, E.

AU - Ólafsson, J.

AU - Szalai, Z.

PY - 2006/11

Y1 - 2006/11

N2 - 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.

AB - 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.

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