- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656409
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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London, United Kingdom, WC1N 3JH
- Great Ormond Street Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Genetically confirmed diagnosis of AT
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Immunogenicity of vaccine
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Secondary Outcome Measures
Outcome Measure |
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Incidence of adverse reactions to vaccine
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Dyskinesias
- DNA Repair-Deficiency Disorders
- Neurocutaneous Syndromes
- Cerebellar Diseases
- Primary Immunodeficiency Diseases
- Spinocerebellar Ataxias
- Ataxia
- Telangiectasis
- Cerebellar Ataxia
- Ataxia Telangiectasia
- Physiological Effects of Drugs
- Immunologic Factors
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- 04MI07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ataxia Telangiectasia (AT)
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Matrix Biomed, Inc.The University of Texas Health Science Center, HoustonNot yet recruitingAtaxia Telangiectasia | Ataxia Telangiectasia Louis-Bar | Ataxia Telangiectasia in ChildrenUnited States
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Johns Hopkins UniversityTerminatedAtaxia-Telangiectasia (A-T)United States
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NHS TaysideUniversity of DundeeCompletedAtaxia-TelangiectasiaUnited Kingdom
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St. Jude Children's Research HospitalNational Cancer Institute (NCI); Children's Hospital of PhiladelphiaCompletedAtaxia-TelangiectasiaUnited States
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University of PlymouthRecruitingAtaxia Telangiectasia | Ataxia Telangiectasia in ChildrenUnited Kingdom
-
The University of QueenslandNational Health and Medical Research Council, AustraliaCompletedAtaxia TelangiectasiaAustralia
-
ErydelBiotrialNot yet recruitingAtaxia TelangiectasiaBelgium, United States, Denmark, Germany, Italy, Norway, Poland, Spain, United Kingdom
-
ErydelRecruitingAtaxia TelangiectasiaUnited States, Australia, Belgium, Germany, India, Italy, Poland, Spain, Tunisia
-
Acasti Pharma Inc.Active, not recruitingAtaxia TelangiectasiaCanada
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University Hospital, AkershusOslo University Hospital; University Hospital of North Norway; University of... and other collaboratorsActive, not recruitingAtaxia TelangiectasiaNorway
Clinical Trials on Conjugated pneumococcal vaccine (Prevenar)
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Hospital Universitari Son DuretaFondo de Investigacion Sanitaria; Hospital Son LlatzerUnknownHIV Infections | HIV | Pneumococcal VaccinesSpain
-
National Taiwan University HospitalNational Science Council, TaiwanUnknown
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type bFrance, Poland
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German-Jordanian UniversityWyeth is now a wholly owned subsidiary of PfizerUnknown
-
The HIV Netherlands Australia Thailand Research...Pediatric infectious diseases section, King Chulalongkorn Memorial hospital...Completed
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Sheba Medical CenterUnknownAtaxia TelangiectasiaIsrael
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Helsinki University Central HospitalCompleted
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CHU de Quebec-Universite LavalGlaxoSmithKline; Canadian Immunization Research NetworkCompletedMeningococcal Infections
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GlaxoSmithKlineCompletedStreptococcus Pneumoniae | Infections, StreptococcalGermany
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University Hospital Southampton NHS Foundation...Solent NHS TrustUnknownPneumococcal Conjugate Vaccine | S. PneumoniaeUnited Kingdom