PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

Karolinska University Hospital

Status and phase

Completed

Phase 2

Conditions

IgG Deficiency

Treatments

Biological: Prevenar13

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01847781

2012-004486-41

Details and patient eligibility

About

The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13) in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the antibody response will be impaired in patients as compared with controls. In contrast, we postulate that the cellular immune response will be intact.

Full description

Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency < 2,8 g/L and/or Immunoglobulin gamma 2-deficiency < 1,15 g/L
Age 18-65

Exclusion criteria

Immunoglobulin gamma-substitution for 6 months prior to study inclusion
Prevenar7 or Prevenar13 given prior to study inclusion.
Pneumovax given during a 2 year period prior to study inclusion
Pregnancy or planning to become pregnant during the study period (4 weeks)
Taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks).
Taking systemic steroids, Non steroidal anti inflammatory drugs (NSAID) or immunosuppressive drugs.
Being allergic to any substance in the vaccine.
Acute and ongoing disease with high fever.
Thrombocytopenia (< 100x109/L).
Coagulopathy
Breastfeeding a baby
The healthy controls should not have any disease with effects on the immune-system