Evaluating typhoid vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.

Phase 4

Active, not recruiting

• Conditions: Specific antibody deficiency; Common variable immunodeficiency; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12621001059853
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-11
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Four groups of participants will be included in this study.
1.Group 1= Adult SAD patients on immunoglobulin replacement awaiting a trial cessation period off immunoglobulin replacement
2.Group 2 = Adult SAD patients on long-term immunoglobulin replacement, due to previously failing a trial off immunoglobulin replacement, or deemed medically not suitable for a trial
3.Group 3 = Adult CVID patients on immunoglobulin replacement
4.Group 4 = Adult healthy controls

General inclusion criteria applicable across the groups includes:
•Consenting adult volunteers 18 years and above.
•Individuals willing to have blood samples collected and attend all study visits.

For Groups 1-3
•Diagnosis of SAD (for Groups 1 and 2) or CVID (Group 3), according to Australian National Blood Authority guidelines, and receiving immunoglobulin replacement (with any product type) for greater than 6 months, at the time of enrolment.

Exclusion Criteria

General exclusion criteria include:
•Age <18 years.
•Individuals unable to provide informed consent.
•Individuals unable to attend study visits.
•Previous allergic reaction to Vi-polysaccharide vaccine or vaccine components.
•Received B cell depletion treatment within the last 2 years (e.g. Rituximab, Ocrelizumab etc.).
•Pregnant or breast-feeding at the time of study enrolment.

Additional exclusion criteria for healthy controls:
- Vi-polysaccharide vaccination within the last 2 years
- Immunosuppressive state including current treatment with immunosuppressive agents, active haematological malignancy, treatment with chemotherapy or radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified