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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01847781
• Date of registration: 01/05/2013
• Prospective Registration: Yes
• Primary sponsor: Karolinska University Hospital
• Public title: PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency PNEUMOCELL
• Scientific title: PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
• Date of first enrolment: May 2013
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01847781
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Peter W Bergman, MD, PhD
• Affiliation: Karolinska University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgG Deficiency

Intervention(s)

Biological: Prevenar13

Primary Outcome(s)

Change in opsonophagocytic antibodies [Time Frame: 4 weeks post-vaccination, change from baseline]

Secondary Outcome(s)

Change in antimicrobial peptides [Time Frame: 4 weeks post-vaccination, change from baseline]

Change in cellular immunity [Time Frame: 4 weeks post-vaccination, change from baseline]

Secondary ID(s)

2012-004486-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer