Clinical Trial: "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 Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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- Pneumococ
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) 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.
Detailed Summary:
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 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.
Secondary objectives :
- Evaluation and comparison the specific antibody response to seven pneumococcal serotypes, shared by the PnCj and PPS vaccines (4, 6B, 9V, 14, 18C, 19F, 23F), and two serotypes of the PPS vaccine (1, 5) 4 weeks after the single (W8 for patients from Group 1) or the first vaccination (W4 for patients from group 2).
- Evaluation of the duration of the specific antibody response at week 24
- Evaluation of the T CD4 lymphocyte response (proliferation and cytokine production) to the CRM protein
- Study of the Immunoglobulin V gene repertoire (immunoscope) before and after vaccination.
- Safety of the vaccines
- Effect of the vaccine strategies on the frequency of Streptococcus pneumoniae infections (bronchitis, sinusitis and recurrent upper respiratory tract)
EXPERIMENTAL METHODS
Study design
Randomised, multicentric, controlled phase II study of the immunological efficacy of a "prime boost" strategy combining the sequential ad
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Current Primary Outcome: proportion of responders to each serotype [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Institut National de la Santé Et de la Recherche Médicale, France
Dates:
Date Received: December 8, 2011
Date Started: June 2009
Date Completion:
Last Updated: February 23, 2016
Last Verified: February 2016