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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00589394 |
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 |
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Healthy |
Other: pneumococcal vaccination (Pneumovax) |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine |
Estimated Enrollment: | 100 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pneumovax is given and the pre and post pneumococcal serology are drawn
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Other: pneumococcal vaccination (Pneumovax)
pneumovax
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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.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: kay bachman, rn | 507-284-1903 | bachman.kay@mayo.edu |
United States, Minnesota | |
Mayo clinic | Recruiting |
rochester, Minnesota, United States, 55902 | |
Contact: kay bachman, rn 507-284-1903 bachman.kay@mayo.edu | |
Principal Investigator: miguel park, md | |
Principal Investigator: miguel park, md |
Principal Investigator: | miguel park, md | Mayo Clinic |
Responsible Party: | mayo clinic ( Miguel Park ) |
Study ID Numbers: | 07-004799 |
Study First Received: | December 28, 2007 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00589394 |
Health Authority: | United States: Institutional Review Board |
pneumoccal vaccine normal response immunodeficiency Healthy patients Healthy Volunteers |
Healthy Immunologic Deficiency Syndromes |