Clinical trial NCT00801957: Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Official title: A Double Blind, Multicentre, Randomised, Parallel Group Study to Demonstrate the Equivalence of the Response to Vaccination of a Tacrolimus Ointment Regimen to a Steroid Ointment Regimen in Children With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
meningitis
vaccination
tacrolimus
steroids
equivalence response
meningococcal vaccine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 260
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.

Detailed description: At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe atopic dermatitis and in need for treatment
* Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C

Exclusion Criteria:

* Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine
* Patients have an acute severe febrile illness, genetic epidermal barrier defect such as Netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area
* Patients have already received a meningo polysaccharide or conjugated vaccine against meningitis

Primary outcomes:
measure: Percentage of patients with serum bactericidal antibody titer of ≥ 8
timeFrame: 5 weeks
Secondary outcomes:
measure: Assessment of other immunological parameters
timeFrame: 7 months
Other outcomes:
Locations:
city: Kogarah
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: Benowa
country: Australia
state: Queensland
city: Carina Heights
country: Australia
state: Queensland
city: Herston
country: Australia
state: Queensland
city: North Adelaide
country: Australia
state: South Australia
city: Carlton
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Leuven
country: Belgium
city: Bretten
country: Germany
city: Ettenheim
country: Germany
city: Gersfeld
country: Germany
city: Kehl
country: Germany
city: Tettnang
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Kopavogur
country: Iceland
city: St. Julians
country: Malta
city: Karpacz
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Opole
country: Poland
city: Poznan
country: Poland
city: Rabka-Zdroj
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Zgierz
country: Poland
city: Lisboa
country: Portugal
city: Porto
country: Portugal
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References:
citation: Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23.