Trial record 9 of 127 for:    Immunodeficiency NOT AIDS | Open Studies

"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 recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
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
  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:


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)

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  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014