"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)
This study is currently recruiting participants.
Verified April 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01489618
First received: December 8, 2011
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Common Variable Immunodeficiency |
Biological: PPS Biological: PnCJ PPS |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
common variable immune deficiency
complement factor I deficiency
U.S. FDA Resources
Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 72 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: PPS
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)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489618
Contacts
| Contact: Yves Lévy, MD | +33(0)1 49 81 24 55 | yves.levy@hmn.aphp.fr |
| Contact: Anne-Sophie LASCAUX-CAMETZ, MD | +33(0)1 49 81 24 55 | anne-sophie.lascaux@hmn.aphp.fr |
Locations
| France | |
| Service d'Immunologie Clinique Hôpital Henri Mondor | Recruiting |
| Creteil, France, 94 010 | |
| Contact: Yves Lévy, MD +33 (0)1 49 81 24 55 yves.levy@hmn.aphp.fr | |
| Contact: Anne-Sophie LASCAUX-CAMETZ, MD +33 (0)1 49 81 24 55 anne-sophie.lascaux@hmn.aphp.fr | |
| Principal Investigator: Yves Lévy, MD | |
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
More Information
No publications provided
| Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT01489618 History of Changes |
| Other Study ID Numbers: | RBM04-34, 2007-003235-23 |
| Study First Received: | December 8, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
|
Common variable immunodeficiency pneumococcal vaccine prime boost |
Additional relevant MeSH terms:
|
Common Variable Immunodeficiency Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013