Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miguel Park, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589394
First received: December 28, 2007
Last updated: January 8, 2016
Last verified: January 2016

December 28, 2007
January 8, 2016
July 2007
December 2008   (final data collection date for primary outcome measure)
Assess IgG antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls [ Time Frame: 4-6 wks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589394 on ClinicalTrials.gov Archive Site
Analysis of B cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory B cell, class switched and activated B cells. [ Time Frame: 4-6 wks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine
The lack of clear guidelines and studies addressing the proper response to the pneumococcal vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency patients. Should an age matched normal response range to the Pneumovax ® be established, it would have a profound impact in the diagnosis, safety and care of immunodeficiency patients. Moreover, characterizing the B cell compartments response to the Pneumovax ® may better delineate the mechanism of protective immunity from Pneumovax ® and provide an additional tool for the diagnosis and care for immunodeficiency patients.

The ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating a patient with immunodeficiency. The pneumococcal vaccine (Pneumovax ®) remains the only readily available and the most widely used unconjugated polysaccharide vaccine. Although the pneumococcal vaccine is widely used test the immune systems response to a polysaccharide antigen, no clear guidelines or studies exist to what is considered a proper response to the Pneumovax ®. Immunoglobulin M (IgM) memory B cells are thought to play an important role in protection against pneumococcal disease. It is not known to what extent the ability of B cells to be activated in response to pneumococcal vaccination contributes to protective immunity. To address these issues, the following two specific aims are proposed:

Specific Aim 1. Assess Immunoglobulin G (IgG) antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls Specific Aim 2. Analysis of B cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory B cell, class switched and activated B cells.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
Biological: pneumococcal vaccination (Pneumovax)
pneumovax was given
pneumococcal vaccination (Pneumovax)

Intervention:

Patients receive one dose of the Pneumovax vaccine. The 23 pneumococcal serotypes are measured before and after vaccination in order to measure response in a healthy population.

Intervention: Biological: pneumococcal vaccination (Pneumovax)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2010
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients from 20 to 70 years of age

Exclusion Criteria:

  • Previous or current diagnosis of an immunodeficiency (primary and secondary)
  • Previous or current diagnosis of a rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, vasculitis), cancer, diabetes, active infection and/or other chronic diseases (multiple sclerosis, etc)
  • Current or previous use (within that last 6 months) of systemic/inhaled corticosteroids, sulfasalazine, and other immunosuppressive agents (cyclosporin, methotrexate, CellCept) anti-convulsants (phenytoin, carbamazepine), gold, d-penicillamine, and anti-malarials (quinine, chloroquine, hydroxychloroquine)
  • Pregnancy
Both
20 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589394
06-005905
Yes
Not Provided
Not Provided
Miguel Park, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Miguel A. Park, MD Mayo Clinic
Mayo Clinic
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP