Polysaccharide Antibody Response Study

Specific Polysaccharide Antibody Deficiency Clinical Trial

— PARS  

Official title:

The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02429531
• Other study ID #: S57605
• Status: Recruiting
• Phase: Phase 4
• First received: February 19, 2015
• Last updated: October 6, 2015
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Heidi Schaballie, MD
• Phone: +3216347229
• Email: heidi.schaballie[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Specific Polysaccharide Antibody Deficiency

Intervention

Biological:
• Pneumovax 23 (Sanofi Pasteur MSD)
Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).
• Typhim Vi (Sanofi Pasteur MSD)
Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Schaballie H, Vermeulen F, Verbinnen B, Frans G, Vermeulen E, Proesmans M, De Vreese K, Emonds MP, De Boeck K, Moens L, Picard C, Bossuyt X, Meyts I. Value of allohaemagglutinins in the diagnosis of a polysaccharide antibody deficiency. Clin Exp Immunol. 2015 May;180(2):271-9. doi: 10.1111/cei.12571. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Typhim Vi response specific anti-Vi IgG as measured by ELISA	specific anti-Vi IgG as measured by ELISA	3-4 weeks	No
Primary	Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA	specific pneumococcal polysaccharide IgG as measured by ELISA	3-4 weeks	No
Secondary	allohemaglutinin titer as measured by column agglutination	bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination	1 day	No
Secondary	ENT infections (number of ENT infections obtained by history and medical file)	number of ENT infections obtained by history and medical file	12 months before inclusion untill inclusion	No
Secondary	pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file)	number of lung infections, confirmed on chest radiography, obtained by history and medical file	5 years before inclusion untill inclusion	No
Secondary	invasive infections (number and infection site of invasive infections obtained by history and medical file)	number and infection site of invasive infections obtained by history and medical file	5 years before inclusion untill inclusion	No
Secondary	bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file)	presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file	5 years before inclusion untill inclusion	No
Secondary	adverse effects	vaccine related adverse effects	4 weeks	Yes