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

NCT00589394 | Completed Phase 1 DMC

• 1 other identifier: 06-005905
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

pneumococcal vaccine; normal response; immunodeficiency; Healthy patients; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Assess IgG antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls

  4-6 wks

Secondary Outcomes (1)

• 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.

  4-6 wks

Study Arms (1)

pneumococcal vaccination (Pneumovax)

OTHER

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)

Interventions

pneumococcal vaccination (Pneumovax) BIOLOGICAL

pneumovax was given

pneumococcal vaccination (Pneumovax)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from 20 to 70 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Miguel A. Park, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 9, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2010
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)