Polysaccharide Antibody Response Study
- Conditions
- Specific Polysaccharide Antibody Deficiency
- Interventions
- Biological: Pneumovax 23 (Sanofi Pasteur MSD)Biological: Typhim Vi (Sanofi Pasteur MSD)
- Registration Number
- NCT02429531
- Lead Sponsor
- Universitaire Ziekenhuizen KU 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
- Informed consent given
- History of serious adverse reaction to a vaccine
- Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
- (Potential) pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients Typhim Vi (Sanofi Pasteur MSD) 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 . Healthy controls Pneumovax 23 (Sanofi Pasteur MSD) Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi . Healthy controls Typhim Vi (Sanofi Pasteur MSD) Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi . Patients Pneumovax 23 (Sanofi Pasteur MSD) 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 .
- Primary Outcome Measures
Name Time Method Typhim Vi response specific anti-Vi IgG as measured by ELISA 3-4 weeks specific anti-Vi IgG as measured by ELISA
Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA 3-4 weeks specific pneumococcal polysaccharide IgG as measured by ELISA
- Secondary Outcome Measures
Name Time Method ENT infections (number of ENT infections obtained by history and medical file) 12 months before inclusion untill inclusion number of ENT infections obtained by history and medical file
bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file) 5 years before inclusion untill inclusion presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file
adverse effects 4 weeks vaccine related adverse effects
pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file) 5 years before inclusion untill inclusion number of lung infections, confirmed on chest radiography, obtained by history and medical file
allohemaglutinin titer as measured by column agglutination 1 day bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination
invasive infections (number and infection site of invasive infections obtained by history and medical file) 5 years before inclusion untill inclusion number and infection site of invasive infections obtained by history and medical file
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium