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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Helsinki University Central Hospital

Current Primary Outcome:

  • Humoral response to vaccination [ Time Frame: 4-6 weeks post-vaccination ]
  • Cell-mediated response to vaccination [ Time Frame: 4-6 wks post-vaccination ]
  • Number and severity of adverse events to vaccination [ Time Frame: 0-60 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Helsinki University Central Hospital

Dates:
Date Received: February 10, 2015
Date Started: February 2015
Date Completion: February 2019
Last Updated: March 1, 2017
Last Verified: March 2017