UZ Leuven
Leuven, 3000, Belgium
NCT Number: NCT02429531
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.
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Notify Me18 month–55 year
All sexes
Interventional
Phase 4
Leuven, 3000, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).
Intramuscular injection of Typhim Vi vaccine (0.5 ml).
Time frame: 3-4 weeks
specific anti-Vi IgG as measured by ELISA
Time frame: 3-4 weeks
specific pneumococcal polysaccharide IgG as measured by ELISA
Time frame: 1 day
bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination
Time frame: 12 months before inclusion untill inclusion
number of ENT infections 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
Time frame: 5 years before inclusion untill inclusion
number and infection site of invasive infections 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
Time frame: 4 weeks
vaccine related adverse effects
Universitaire Ziekenhuizen KU Leuven
Other
The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency
Acronym: PARS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.