Study of the value of alternative methods to pneumococcal polysaccharide vaccine response for diagnosis of a specific polysaccharide antibody deficiency. Specific polysaccharide antibody deficiency is an immunodeficiency characterized by a deficient production of antibodies to the cell wall of encapsulated bacteria, leading to recurrent ENT and lung infections.

The Polysaccharide Antibody Response Study: Typhim Vi response and allohemagglutinins versus Pneumo 23 vaccine response in the diagnosis of Specific Polysaccharide Antibody Deficiency. - PAR-study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003007-29-BE

Enrollment

Unknown

Registered

2015-07-24

Start date

2015-08-12

Completion date

Unknown

Last updated

2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specific polysaccharide antibody deficiency.

Interventions

Trade Name: Pneumovax 23 Pharmaceutical Form: Solution for injection in pre-filled syringe Trade Name: Typhim Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cohort 1: Subjects, in whom humoral immunity is evaluated, will be included in cohort 1 when the below-mentioned criteria are fulfilled. • Assessment of polysaccharide antibody response is indicated for the clinical care of the patient • Age between 18 months and 55 years • Informed consent given Cohort 2: Healthy volunteers, recruited at the travel clinic and by advertising, will be included in cohort 2 when the below-mentioned criteria are fulfilled. • Age between 18 months and 55 years • Informed consent given Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Age >55 years • Age <18 months • History of serious adverse reaction to a vaccine • Vaccination with Typhim or Pneumovax 23 in 5 years prior to the study • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to assess the diagnostic value of the Typhim antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency. Primary objective: • To establish whether antibody response to Typhim in patients with suspected PID (1) and in healthy adults (2) is non-inferior relative to the antibody response to Pneumovax 23. • To assess the correlation between Typhim antibody response and the pneumococcal antibody response. ;Secondary Objective: • To establish whether allohemagglutinin titers in patients with suspected PID (1) and in healthy subjects (2) are non-inferior relative to the antibody response to Pneumovax 23. • To establish normal values for Typhim response and allohemagglutinins in healthy adults. • To correlate the measured antibody response to the clinical phenotype. ;Primary end point(s): • Sensitivity and specificity, predictive values and likelihood ratios of low Salmonella typhi capsular Vi response, with Pneumovax 23 as a reference standard. • Correlation between Pneumovax 23 antibody response and Typhim antibody response. ;Timepoint(s) of evaluation of this end point: At inclusion of 100 subjects and at inclusion end.	—

Measure

Time frame

Main Objective: The purpose of this study is to assess the diagnostic value of the Typhim antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency. Primary objective: • To establish whether antibody response to Typhim in patients with suspected PID (1) and in healthy adults (2) is non-inferior relative to the antibody response to Pneumovax 23. • To assess the correlation between Typhim antibody response and the pneumococcal antibody response. ;Secondary Objective: • To establish whether allohemagglutinin titers in patients with suspected PID (1) and in healthy subjects (2) are non-inferior relative to the antibody response to Pneumovax 23. • To establish normal values for Typhim response and allohemagglutinins in healthy adults. • To correlate the measured antibody response to the clinical phenotype. ;Primary end point(s): • Sensitivity and specificity, predictive values and likelihood ratios of low Salmonella typhi capsular Vi response, with Pneumovax 23 as a reference standard. • Correlation between Pneumovax 23 antibody response and Typhim antibody response. ;Timepoint(s) of evaluation of this end point: At inclusion of 100 subjects and at inclusion end.

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Secondary

Measure	Time frame
Secondary end point(s): • Sensitivity and specificity, predictive values and likelihood ratios of low allohemagglutinin titers, with Pneumovax 23 as a reference standard. • Receiver Operating Characteristic (ROC) curves for Typhim response and allohemagglutinins will be calculated using Pneumovax 23 as the reference standard to identify polysaccharide antibody deficient subjects. • Association of low allohemagglutinins and low Typhim response to clinical signs of polysaccharide specific antibody deficiency (recurrent respiratory tract infections, bronchiectasis). ;Timepoint(s) of evaluation of this end point: At inclusion of 100 subjects and at inclusion end.	—

Measure

Time frame

Secondary end point(s): • Sensitivity and specificity, predictive values and likelihood ratios of low allohemagglutinin titers, with Pneumovax 23 as a reference standard. • Receiver Operating Characteristic (ROC) curves for Typhim response and allohemagglutinins will be calculated using Pneumovax 23 as the reference standard to identify polysaccharide antibody deficient subjects. • Association of low allohemagglutinins and low Typhim response to clinical signs of polysaccharide specific antibody deficiency (recurrent respiratory tract infections, bronchiectasis). ;Timepoint(s) of evaluation of this end point: At inclusion of 100 subjects and at inclusion end.

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Countries

Belgium

Contacts

Public ContactClinical Trial Center

University Hospitals Leuven

ctc@uzleuven.be321634 19 98

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026