Status:
TERMINATED
"Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Common Variable Immunodeficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The main objective of this study is to evaluate and to compare the specific antibody response to a " prime-boost " vaccine strategy combining the seven valence pneumococcal conjugate vaccine (PnCj) pr...
Detailed Description
Main objective : The main objective of this study is to evaluate and to compare the specific antibody response to a " prime-boost " vaccine strategy combining the seven valence pneumococcal conjugate...
Eligibility Criteria
Inclusion
- Age \> 18 years and \< 65 years
- Common variable immunodeficiency according to the WHO criteria,
- Patients treated with intravenous or subcutaneous immunoglobulin.
- Written informed consent
- Absence of acute infections, or other evolutive diseases related to the (cancer, auto-immune disease…)
Exclusion
- IgG subclass deficiency
- IgA selective deficiency,
- Other primary humoral deficiency (X-linked agammaglobulinemia, Hyper IgM syndrome),
- Long course treatment with corticosteroids \> 5mg per day
- Chemotherapy in the last 3 years,
- Prior pneumococcal vaccination in the last 2 years.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01489618
Start Date
June 1 2009
End Date
March 1 2013
Last Update
February 24 2016
Active Locations (1)
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1
Service d'Immunologie Clinique Hôpital Henri Mondor
Créteil, France, 94 010