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Polysaccharide Antibody Response Study (PARS)

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ClinicalTrials.gov Identifier: NCT02429531
Recruitment Status : Unknown
Verified October 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : April 29, 2015
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency.

Condition or disease Intervention/treatment Phase
Specific Polysaccharide Antibody Deficiency Biological: Pneumovax 23 (Sanofi Pasteur MSD) Biological: Typhim Vi (Sanofi Pasteur MSD) Phase 4

Detailed Description:

Healthy controls (n = 100) and patients with suspected SPAD (n = 100) will be immunized with both Pneumovax 23 and Typhim Vi (age 18 months - 55 years). Analyses of anti-pneumococcal polysaccharide antibodies and anti-Vi antibodies are performed before and 3-4 weeks after vaccination. Also bloodgroup and anti-A/anti-B are assessed. Relevant clinical information (ENT infections, lung infections, bronchiectasis, invasive infections) is obtained from the patient file and history and is noted in a Case Report Form.

The diagnostic performance of Typhim Vi response and allohemagglutinins will be analyzed by calculating sensitivity, specificity, predictive values, likelihood ratios and Receiver Operating Characteristic curves for Typhim Vi and allohemagglutinins using pneumococcal antibody response as the reference standard. The association between low Typhim Vi response or low allohemagglutinins and clinical signs of polysaccharide antibody deficiency will be studied by multiple logistic regression.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency
Study Start Date : October 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Healthy controls
Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi .
Biological: Pneumovax 23 (Sanofi Pasteur MSD)
Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Biological: Typhim Vi (Sanofi Pasteur MSD)
Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Experimental: Patients
Patients presenting for immune evaluation because of recurrent ENT/lung infection or invasive infection with encapsulated bacteria, in whom evaluation of pneumococcal antibody response is indicated, will be immunized with both Pneumovax 23 and Typhim Vi .
Biological: Pneumovax 23 (Sanofi Pasteur MSD)
Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Biological: Typhim Vi (Sanofi Pasteur MSD)
Intramuscular injection of Typhim Vi vaccine (0.5 ml).




Primary Outcome Measures :
  1. Typhim Vi response specific anti-Vi IgG as measured by ELISA [ Time Frame: 3-4 weeks ]
    specific anti-Vi IgG as measured by ELISA

  2. Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA [ Time Frame: 3-4 weeks ]
    specific pneumococcal polysaccharide IgG as measured by ELISA


Secondary Outcome Measures :
  1. allohemaglutinin titer as measured by column agglutination [ Time Frame: 1 day ]
    bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination

  2. ENT infections (number of ENT infections obtained by history and medical file) [ Time Frame: 12 months before inclusion untill inclusion ]
    number of ENT infections obtained by history and medical file

  3. pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file) [ Time Frame: 5 years before inclusion untill inclusion ]
    number of lung infections, confirmed on chest radiography, obtained by history and medical file

  4. invasive infections (number and infection site of invasive infections obtained by history and medical file) [ Time Frame: 5 years before inclusion untill inclusion ]
    number and infection site of invasive infections obtained by history and medical file

  5. bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file) [ Time Frame: 5 years before inclusion untill inclusion ]
    presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file

  6. adverse effects [ Time Frame: 4 weeks ]
    vaccine related adverse effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
  • Informed consent given

Exclusion Criteria:

  • History of serious adverse reaction to a vaccine
  • Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
  • (Potential) pregnancy

Information from the National Library of Medicine

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): NCT02429531


Contacts
Contact: Heidi Schaballie, MD +3216347229 heidi.schaballie@uzleuven.be
Contact: Isabelle Meyts, MD, PhD +3216343842 isabelle.meyts@uzleuven.be

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Heidi Schaballie, MD    016347229    heidi.schaballie@uzleuven.be   
Contact: Isabelle Meyts, MD, PhD    016343842    isabelle.meyts@uzleuven.be   
Sub-Investigator: Xavier Bossuyt, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
Principal Investigator: Isabelle Meyts, MD, PhD UZ Leuven

Publications:
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02429531     History of Changes
Other Study ID Numbers: S57605
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Universitaire Ziekenhuizen Leuven:
Pneumovax 23
Typhim Vi
allohemagglutinins

Additional relevant MeSH terms:
Vaccines
Antibodies
Immunoglobulins
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs