Clinical Trial: Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)

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.

Detailed Summary:
Sponsor: Institute of Child Health

Current Primary Outcome: Immunogenicity of vaccine

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse reactions to vaccine

Original Secondary Outcome: Same as current

Information By: Institute of Child Health

Dates:
Date Received: April 7, 2008
Date Started: June 2006
Date Completion:
Last Updated: April 10, 2008
Last Verified: April 2008