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Immunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox

Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cartilage-hair Hypoplasia

Intervention: Varilrix (Biological)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Helsinki University Central Hospital

Official(s) and/or principal investigator(s):
Outi Mäkitie, PhD, Study Director, Affiliation: Helsinki University Central Hospital and University of Helsinki, Folkhälsan Research Centre, Helsinki Finland

Summary

The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will be selected on the basis of disease severity and the degree of immunodeficiency (including CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV related symptoms, consistent with the current practices. The investigators will verify the development of immune response to vaccination by testing for VZV antibodies and cell-mediated immunity.

Clinical Details

Official title: Immunodeficiency in Cartilage-hair Hypoplasia: Correlation With Pulmonary Disease, Infections and Malignancy

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Humoral response to vaccination

Cell-mediated response to vaccination

Number and severity of adverse events to vaccination

Eligibility

Minimum age: 12 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- genetically confirmed cartilage-hair hypoplasia diagnosis

- age >12 months

- no history of chickenpox

- informed concent of the patient/caregiver.

Exclusion Criteria:

- 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

Locations and Contacts

Additional Information

Starting date: February 2015
Last updated: March 3, 2015

Page last updated: August 23, 2015

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