Evaluating typhoid vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.
Evaluating Vi-polysaccharide vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.
Melbourne Health
40 participants
Jan 18, 2022
Interventional
Conditions
Summary
Patients with specific antibody deficiency (SAD) have impaired immune function and suffer from recurrent infections. Some patients are treated with immunoglobulin replacement which involves receiving monthly infusions of pooled protective antibodies from healthy blood donors. This multi-centre study will be the first to investigate vaccine responses to a commonly used typhoid vaccine (Vi-polysaccharide; Vi-PS) in adult patients with SAD on immunoglobulin replacement. We hypothesise that Vi-PS vaccine responses will differ between SAD patients, in particular those who require long-term immunoglobulin replacement and those with less severe disease. This study will describe Vi-PS vaccine responses in SAD patients both on and off immunoglobulin replacement as well as healthy adults and patients with known antibody deficiency (common variable immunodeficiency). These groups will help us to understand normal and abnormal Vi-PS vaccine responses. Having more information on how to assess SAD patients on immunoglobulin replacement will help clinicians to better manage patients with SAD in the future.
Eligibility
Inclusion Criteria9
- Four groups of participants will be included in this study.
- Group 1= Adult SAD patients on immunoglobulin replacement awaiting a trial cessation period off immunoglobulin replacement
- 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
- Group 3 = Adult CVID patients on immunoglobulin replacement
- Group 4 = Adult healthy controls
- 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 Criteria8
- 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.
- Vi-polysaccharide vaccination within the last 2 years
- Immunosuppressive state including current treatment with immunosuppressive agents, active haematological malignancy, treatment with chemotherapy or radiotherapy.
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Interventions
Single dose of Vi-polysaccharide vaccine (0.5ml intramuscular injection)
Locations(3)
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ACTRN12621001059853