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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589394
First received: December 28, 2007
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Healthy
Other: pneumococcal vaccination (Pneumovax)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Assess IgG antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls [ Time Frame: 4-6 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: July 2007
Study Completion Date: January 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pneumovax is given and the pre and post pneumococcal serology are drawn
Other: pneumococcal vaccination (Pneumovax)
pneumovax

Detailed Description:

The ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating a patient with immunodeficiency [1]. The pneumococcal vaccine (Pneumovax ®) remains the only readily available and the most widely used unconjugated polysaccharide vaccine [2]. 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 ®. 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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589394

Locations
United States, Minnesota
Mayo clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: miguel park, md Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Miguel Park, mayo clinic
ClinicalTrials.gov Identifier: NCT00589394     History of Changes
Other Study ID Numbers: 07-004799
Study First Received: December 28, 2007
Last Updated: July 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
pneumoccal vaccine
normal response
immunodeficiency
Healthy patients
Healthy Volunteers

ClinicalTrials.gov processed this record on November 25, 2014