- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00001173
Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
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Samarbejdspartnere og efterforskere
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Studiestart
Studieafslutning
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Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 800070
- 80-I-0070
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