"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

NCT01489618 | Terminated Phase 2 DMC

• 2 other identifiers: RBM04-342007-003235-23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Variable Immunodeficiency

Keywords

Common variable immunodeficiency; pneumococcal vaccine; prime boost

Outcome Measures

Primary Outcomes (1)

• proportion of responders to each serotype

  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.

  8 weeks

Study Arms (2)

PPS

ACTIVE COMPARATOR

Group 1: patients will a single administration of the PPS (one dose at W4). 25 patients will be randomised in this group.

Biological: PPS

PnCJ PPS

EXPERIMENTAL

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

Interventions

PPS BIOLOGICAL

POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE

PPS

PnCJ PPS BIOLOGICAL

PRIMEBOOST CONJUGATED ANTI- PNEUMOCOCCAL VACCINE (Week 0) POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE (Week 4)

PnCJ PPS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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…)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Service d'Immunologie Clinique Hôpital Henri Mondor

Créteil, 94 010, France

Location

MeSH Terms

Conditions

Common Variable Immunodeficiency

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 9, 2011
• Study Start: June 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

FR (1)