Clinical Trial: Polysaccharide Antibody Response Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody De
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.
Detailed Summary:
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.
Sponsor: Universitaire Ziekenhuizen Leuven
Current Primary Outcome:
- Typhim Vi response specific anti-Vi IgG as measured by ELISA [ Time Frame: 3-4 weeks ]specific anti-Vi IgG as measured by ELISA
- Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA [ Time Frame: 3-4 weeks ]specific pneumococcal polysaccharide IgG as measured by ELISA
Original Primary Outcome: Same as current
Current Secondary Outcome:
- allohemaglutinin titer as measured by column agglutination [ Time Frame: 1 day ]bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination
- 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
- 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
- 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
- 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
- adverse effects [ Time Frame: 4 weeks ]vaccine related adverse effects
Original Secondary Outcome: Same as current
Information By: Universitaire Ziekenhuizen Leuven
Dates:
Date Received: February 19, 2015
Date Started: October 2015
Date Completion: October 2016
Last Updated: October 6, 2015
Last Verified: October 2015
