Immunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02383797 |
Recruitment Status :
Active, not recruiting
First Posted : March 9, 2015
Last Update Posted : October 22, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cartilage-hair Hypoplasia | Biological: Varilrix | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunodeficiency in Cartilage-hair Hypoplasia: Correlation With Pulmonary Disease, Infections and Malignancy |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | October 2019 |
Estimated Study Completion Date : | February 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Biological: Varilrix
Vaccination against varicella in selected cartilage-hair hypoplasia patients
Other Name: ATC J07BK01 |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383797
Study Director: | Outi Mäkitie, PhD | Helsinki University Central Hospital and University of Helsinki, Folkhälsan Research Centre, Helsinki Finland |
Responsible Party: | Paula Klemetti, MD, PhD, Consultant in pediatric gastroenterology and immunology, Helsinki University Central Hospital |
ClinicalTrials.gov Identifier: | NCT02383797 |
Other Study ID Numbers: |
TYH2013336 |
First Posted: | March 9, 2015 Key Record Dates |
Last Update Posted: | October 22, 2019 |
Last Verified: | October 2019 |
Osteochondrodysplasias Hirschsprung Disease Immunologic Deficiency Syndromes Immune System Diseases Digestive System Abnormalities Digestive System Diseases Megacolon Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Congenital Abnormalities Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn |