Polysaccharide Antibody Response Study

NCT ID: NCT02429531

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-08-31

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.

Conditions

Specific Polysaccharide Antibody Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy controls

Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi .

Group Type: EXPERIMENTAL

Pneumovax 23 (Sanofi Pasteur MSD)

Intervention Type: BIOLOGICAL

Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Typhim Vi (Sanofi Pasteur MSD)

Intervention Type: BIOLOGICAL

Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Patients

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 .

Group Type: EXPERIMENTAL

Pneumovax 23 (Sanofi Pasteur MSD)

Intervention Type: BIOLOGICAL

Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Typhim Vi (Sanofi Pasteur MSD)

Intervention Type: BIOLOGICAL

Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Interventions

Pneumovax 23 (Sanofi Pasteur MSD)

Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).

Intervention Type: BIOLOGICAL

Typhim Vi (Sanofi Pasteur MSD)

Intramuscular injection of Typhim Vi vaccine (0.5 ml).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Meyts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 25516411 (View on PubMed)

Other Identifiers

S57605

Identifier Type: -

Identifier Source: org_study_id