ClinicalTrials.gg
Status unknownNCT02383797Updated Oct 22, 2019

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

A Phase 4 interventional study of Varilrix in Cartilage-hair Hypoplasia, sponsored by Helsinki University Central Hospital. Status unknown. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
12 Months and older
Sex
All
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Study 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.

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Conditions studied

  • Cartilage-hair Hypoplasia
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In context

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • genetically confirmed cartilage-hair hypoplasia diagnosis
  • age >12 months
  • no history of chickenpox
  • informed concent of the patient/caregiver.

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalVarilrix

    Vaccination against varicella in selected cartilage-hair hypoplasia patients

    Also known as: ATC J07BK01

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What researchers measure

Primary outcomes

  1. Humoral response to vaccination

    Time frame: 4-6 weeks post-vaccination

  2. Cell-mediated response to vaccination

    Time frame: 4-6 wks post-vaccination

  3. Number and severity of adverse events to vaccination

    Time frame: 0-60 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Vakkilainen 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. PubMed 32849667 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02383797
Responsible party
Paula Klemetti (MD, PhD, Consultant in pediatric gastroenterology and immunology, Helsinki University Central Hospital) — Principal investigator
First posted
Mar 9, 2015
Start date
Feb 2015
Primary completion
Oct 2019
Completion
Feb 2020 (estimated)
Last update
Oct 22, 2019

Study contacts

Outi Mäkitie, PhD
study director · Helsinki University Central Hospital and University of Helsinki, Folkhälsan Research Centre, Helsinki Finland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Chickenpox Vaccine

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