Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02383797
Other study ID # TYH2013336
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 2015
Est. completion date February 2020

Study information

Verified date October 2019
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date February 2020
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 12 Months and older
Eligibility 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

Study Design


Intervention

Biological:
Varilrix
Vaccination against varicella in selected cartilage-hair hypoplasia patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Humoral response to vaccination 4-6 weeks post-vaccination
Primary Cell-mediated response to vaccination 4-6 wks post-vaccination
Primary Number and severity of adverse events to vaccination 0-60 days