Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00589394

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:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

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

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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

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 February 12, 2012