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

IgG Deficiency Clinical Trial

— PNEUMOCELL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847781
• Other study ID #: 2012-004486-41
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2013
• Last updated: June 13, 2014
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• IgG Deficiency

Intervention

Biological:
• Prevenar13

Locations

Country	Name	City	State
Sweden	Immunedeficiency Unit, Karolinska University Hospital, Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in opsonophagocytic antibodies	Titers of opsonophagocytic antibodies will be measured at baseline and 4 weeks post-vaccination. Titers from 4 weeks post-vaccination will be compared with baseline-levels.	4 weeks post-vaccination, change from baseline	No
Secondary	Change in cellular immunity	PBMCs will be collected and stimulated with vaccine-antigens. Cellular activation markers and cytokine release will be measured and results from 4 weeks post-vaccination will be compared with baseline-levels.	4 weeks post-vaccination, change from baseline	No
Secondary	Change in antimicrobial peptides	Levels of AMPs in nasal fluid will be measured at 0 and 4 weeks post-vaccination. Results from 4 weeks will be compared with base-line levels.	4 weeks post-vaccination, change from baseline	No