Skip to main content
OpenTrials
Completed

NCT Number: NCT02429531

Polysaccharide Antibody Response Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 month–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumovax 23 (Sanofi Pasteur MSD)

Biological

Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Typhim Vi (Sanofi Pasteur MSD)

Biological

Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2015
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.