Patients with IgG-deficiency
Conditions
Interventions
Trade Name: Prevenar13
Product Name: Prevenar13
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
Karolinska University Hospital, Huddinge, Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patients should have been diagnosed with IgG-deficiency; IgG1=65 years) no F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. The patient should not have been given Prevenar 7 or 13 prior to the study inclusion. 2. The patient should not have been given PPV23 2 years prior to the study inclusion. 3. The patient should not be pregnant. 4. The patient should not take part in any other clinical study involving drugs or vaccines. The healthy controls should be healthy and not be on any drugs that could interfere with an immune response (systemic steroids, NSAIDs, immunosuppressive drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study opsonizing IgG after vaccination with a conjugated pneumococcal vaccine given to patients with IgG-deficiency.;Secondary Objective: To study cellular immune responses after vaccination with a conjugated pneumococcal vaccine given to patients with IgG-deficiency.;Primary end point(s): Opsonophagocytic activity of pre- and postvaccination titers, respectively.;Timepoint(s) of evaluation of this end point: We will compare titer after 4 weeks with baseline, but will also evaluate titers after 1 and 2 weeks post vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cellular immune-responses against penumococcal vaccine strains.;Timepoint(s) of evaluation of this end point: The cellular immune response will be evaluated at time=0, 1 week, 2 weeks and 4 weeks, where the secondary endpoint is the difference between baseline and 4 weeks. | — |
Countries
Sweden
Contacts
Public ContactPeter Bergman
Karolinska University Hospital, Huddinge, Sweden
Outcome results
None listed