Cartilage-hair hypoplasia patients.
Conditions
Interventions
Trade Name: VARILRIX
Product Name: VARILRIX
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: VARILRIX (VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED)
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Genetically confirmed cartilage-hair hypoplasia diagnosis, age >12 months, no history of chickenpox, negative serology to varicella zoster virus, CD4+ cell counts = 15% or = 200 cells/mm3, no clinical nor laboratory signs of severe immunodeficiency, informed concent of the patient/caregiver. Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age <12 months, positive serum IgG for varicella zoster virus, low CD4+ cell counts (<15% or <200 cells/mm3), clinical or laboratory signs of severe immunodeficiency, ongoing intravenous or subcutaneous immunoglobulin treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to prove that vaccination against chickenpox is safe and effective in cartilage-hair hypoplasia patients.;Secondary Objective: Not applicable;Primary end point(s): Immune response to vaccination tested by measuring VZV antibodies and cell-mediated immunity. ;Timepoint(s) of evaluation of this end point: 4-6 weeks post-vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No or mild symptoms post-vaccination.;Timepoint(s) of evaluation of this end point: 6 weeks post-vaccination. Symptoms may be reported by patients/caregivers later as well. | — |
Countries
Finland
Contacts
Public ContactChildren's Hospital
Helsinki University Central Hospital
Outcome results
None listed