Vaccination of antibody deficient patients with Prevenar13 - a comparative study between antibody response and cellular immunity.

Phase 1

Conditions: Patients with IgG-deficiency
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2012-004486-41-SE

Lead Sponsor: Karolinska University Hospital, Huddinge, Sweden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. The patients should have been diagnosed with IgG-deficiency; IgG1<2.8 g/l and/or IgG2<1.15 g/L.
2. The patient should be between 18-65 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.