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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

NCT05084508

Chickenpox

COMPLETED PHASE2

Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

NCT00792623

Varicella

COMPLETED PHASE2

Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

NCT03685682

Varicella Zoster Vaccine

COMPLETED PHASE3

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

NCT03493776

Varicella Zoster Vaccine

UNKNOWN PHASE4

Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

NCT00338442

Varicella

APPROVED_FOR_MARKETING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cartilage-hair Hypoplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cartilage-hair hypoplasia (CHH)

Selected CHH patients will be vaccinated against varicella with Varilrix, one dose of 0,5 ml subcutaneously. If no response is documented to the first dose, the second dose of 0,5 ml can be administered.

Group Type EXPERIMENTAL

Varilrix

Intervention Type BIOLOGICAL

Vaccination against varicella in selected cartilage-hair hypoplasia patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Varilrix

Vaccination against varicella in selected cartilage-hair hypoplasia patients

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ATC J07BK01

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No