Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization

Healthy Clinical Trial

Official title:

Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001173
• Other study ID #: 800070
• Secondary ID: 80-I-0070
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: June 1980
• Est. completion date: June 2000

Study information

• Verified date: June 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

One of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce antibodies. We are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number 77-I-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man.

Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess B cell related immunologic profiles in patients and control normal subjects. We have recently developed a sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus toxoid. This will allow us to carefully and precisely monitor the evolution and immunoregulation of the human B cell responses to this recall antigen. This is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

Description:

One of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce antibodies. We are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number 77-I-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man.

Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess B cell related immunologic profiles in patients and control normal subjects. We have recently developed a sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus toxoid. This will allow us to carefully and precisely monitor the evolution and immunoregulation of the human B cell responses to this recall antigen. This is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Male and female patients 18 years and older.

Patients admitted to the Clinical Center under other approved research protocols designed to investigate immune mediated or inflammatory diseases and who have not been immunized to tetanus toxoid within 6 months.

No pregnant women.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy
• Tetanus

Locations

Country	Name	City	State
United States	National Institute of Allergy and Infectious Diseases (NIAID)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,