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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589394
First Posted: January 9, 2008
Last Update Posted: January 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miguel Park, Mayo Clinic
  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 Phase
Healthy Biological: pneumococcal vaccination (Pneumovax) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Miguel Park, Mayo Clinic:

Primary Outcome Measures:
  • Assess IgG antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls [ Time Frame: 4-6 wks ]

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 ]

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
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.

Biological: pneumococcal vaccination (Pneumovax)
pneumovax was given

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589394


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Miguel A. Park, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Miguel Park, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589394     History of Changes
Other Study ID Numbers: 06-005905
First Submitted: December 28, 2007
First Posted: January 9, 2008
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Miguel Park, Mayo Clinic:
pneumococcal vaccine
normal response
immunodeficiency
Healthy patients
Healthy Volunteers

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs