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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | June 1980 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001173 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization |
| Official Title ICMJE | Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization |
| Brief 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. |
| Detailed 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 200 |
| Completion Date | June 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001173 |
| Responsible Party | |
| Study ID Numbers ICMJE | 800070, 80-I-0070 |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 1999 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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