Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
Primary Purpose
Ataxia Telangiectasia (AT)
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Conjugated pneumococcal vaccine (Prevenar)
Sponsored by
About this trial
This is an interventional basic science trial for Ataxia Telangiectasia (AT) focused on measuring Ataxia telangiectasia,, Conjugated pneumococcal,, Prevenar,, Immunogenicity ,, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Genetically confirmed diagnosis of AT
Sites / Locations
- Great Ormond Street Hospital
Outcomes
Primary Outcome Measures
Immunogenicity of vaccine
Secondary Outcome Measures
Incidence of adverse reactions to vaccine
Full Information
NCT ID
NCT00656409
First Posted
April 7, 2008
Last Updated
April 10, 2008
Sponsor
Institute of Child Health
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00656409
Brief Title
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
Official Title
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Child Health
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the second year of life, and affecting predominantly the cerebellum. They also develop the characteristic superficial telangiectases. Between 60 and 80% of affected children are immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23 and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent sino-pulmonary infections but a recent study suggests poor correlation between immune status and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute to the development of chronic lung disease and bronchiectasis. Preventative management includes continuous prophylactic antibiotic treatment in some with the need for replacement immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably effective in this situation but the emergence of resistance amongst community acquired pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also have a role.
This study is designed to look at antibody responses in a one versus two dose regimen in a cohort of AT patients recruited through the AT Society a national charitable organisation involved in providing support to families with this condition and in fostering education and research in the field.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia Telangiectasia (AT)
Keywords
Ataxia telangiectasia,, Conjugated pneumococcal,, Prevenar,, Immunogenicity ,, Vaccine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Conjugated pneumococcal vaccine (Prevenar)
Other Intervention Name(s)
Prevenar
Primary Outcome Measure Information:
Title
Immunogenicity of vaccine
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions to vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Genetically confirmed diagnosis of AT
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
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