None listed
Conditions
Brief 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.
Interventions
Single dose of Vi-polysaccharide vaccine (0.5ml intramuscular injection)
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed