"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 (EVAD)
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) prime at W0 followed by the administration of the pneumococcal capsular polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.
Common Variable Immunodeficiency
Biological: PnCJ PPS
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Randomised, Multicentric, Phase ii Study of the Immunogenicity of a "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|
- proportion of responders to each serotype [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The primary end point of this study is the proportion of responders to each serotype contained in the PnjC vaccine in the two groups of this study according to 4 categories: 5-7; 3-4; 2-1 and 0. A responder is defined by a rise (at least two fold from baseline) of antibody titers specific to pneumococcal serotypes.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: PPS
Group 1: patients will a single administration of the PPS (one dose at W4). 25 patients will be randomised in this group.
POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE
Experimental: PnCJ PPS
Group 2: patients will receive a first boost with the PnCj (one dose at W0) and then one administration of the PPS vaccines (one dose at W4). 47 patients will be randomised in this group.
Biological: PnCJ PPS
PRIMEBOOST CONJUGATED ANTI- PNEUMOCOCCAL VACCINE (Week 0) POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE (Week 4)
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|Contact: Yves Lévy, MD||+33(0)1 49 81 24 email@example.com|
|Contact: Anne-Sophie LASCAUX-CAMETZ, MD||+33(0)1 49 81 24 firstname.lastname@example.org|
|Service d'Immunologie Clinique Hôpital Henri Mondor||Recruiting|
|Creteil, France, 94 010|
|Contact: Yves Lévy, MD +33 (0)1 49 81 24 55 email@example.com|
|Contact: Anne-Sophie LASCAUX-CAMETZ, MD +33 (0)1 49 81 24 55 firstname.lastname@example.org|
|Principal Investigator: Yves Lévy, MD|