Clinical trial · Interventional
Immunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox
Immunodeficiency in Cartilage-hair Hypoplasia: Correlation With Pulmonary Disease, Infections and Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cartilage-hair Hypoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Varilrix | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cartilage-hair hypoplasia (CHH)
- description
- 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.
- interventionNames
- Biological: Varilrix
Primary outcomes (3)
- measure
- Humoral response to vaccination
- timeFrame
- 4-6 weeks post-vaccination
- measure
- Cell-mediated response to vaccination
- timeFrame
- 4-6 wks post-vaccination
- measure
- Number and severity of adverse events to vaccination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVakkilainen S, Kleino I, Honkanen J, Salo H, Kainulainen L, Grasbeck M, Kekalainen E, Makitie O, Klemetti P. The Safety and Efficacy of Live Viral Vaccines in Patients With Cartilage-Hair Hypoplasia. Front Immunol. 2020 Aug 11;11:2020. doi: 10.3389/fimmu.2020.02020. eCollection 2020. PMID 32849667