"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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01489618|
Recruitment Status : Terminated (End of production)
First Posted : December 9, 2011
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Common Variable Immunodeficiency||Biological: PPS Biological: PnCJ PPS||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
U.S. FDA Resources
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)
- proportion of responders to each serotype [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489618
|Service d'Immunologie Clinique Hôpital Henri Mondor|
|Creteil, France, 94 010|