Immune Responses to Mycobacterium Tuberculosis

NCT00340990 | Completed

• 2 other identifiers: 99990400904-I-N009
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted at the University of Mali in the capital city of Bamako, will investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the organism that causes tuberculosis. Tuberculosis is a major global health problem whose solution requires development of an effective vaccine. However, incomplete understanding of how immunity to MTB is acquired and measured limits vaccine development. This study will focus on certain immune system cells - CD4+ T cells - that appear to be very important in fighting tuberculosis. Individuals 16 years of age and older who have or have not been exposed to either tuberculosis or HIV, or both, may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, review of medical records and laboratory tests, and, if medically indicated, a chest x-ray. Individuals whose medical records indicate a past history of tuberculosis or a positive test for exposure to tuberculosis will have a tuberculin skin test. For this test, a few drops of fluid are placed under the skin to see if the immune system reacts to the substance, indicating previous exposure to MTB. Participants will come to the University of Mali 10 times over a 1-year period - 7 times within the first 3 months of the study and then once every 3 months until 1 year after enrollment. At each study visit, they will be asked about their medical history and will donate 75 milliliters (about 1/3 cup) of blood, totaling 830 mL over the entire year. More blood may be requested if the participant's immune system reacts strongly to MTB in laboratory tests. No more than 450 mL (2 cups) of blood would be collected every 6 weeks; this amount is the Red Cross limit for regular blood donations every 6 weeks. The blood samples will be used for tests that measure the level of immunity to tuberculosis. Genetic tests may be performed on blood cells to help interpret special tests of immunity. Because HIV-infected people are included in the study, the findings may also provide information on how HIV renders vulnerability to opportunistic infections, including tuberculosis.

Conditions

Mycobacterium Tuberculosis

Keywords

Tuberculosis; HIV; CD4+ T Cell; Interferon-Gamma; Lymphocyte Proliferation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to sign informed consent and willingness to comply with study requirements (including storage of blood specimens for future research on HIV, AIDS, MTB or the immune system).
• Group A (HIV-/MTB\[BCG\]) HIV ELISA(2) negative; BCG vaccinated with TST(2) less than 15 mm
• Group B (HIV+/MTB\[BCG\]) HIV ELISA/WB(2) positive; BCG vaccinated with TST less than 5 mm
• Group C (HIV-/MTB\[pulm\]) HIV ELISA negative; pulmonary MTB
• Group D (HIV-/MTB\[diss\]) HIV ELISA negative; disseminated MTB
• Group E (HIV+/MTB\[pulm\]) HIV ELISA/WB positive; pulmonary MTB
• Group F (HIV+/MTB\[diss\]) HIV ELISA/WB positive; disseminated MTB

You may not qualify if:

• Age less than 18 years (because of the risk for inducing protocol-related anemia)
• Hg less than 7.5 g/dL
• Latent MTB infection (as evidenced by a TST greater than 5 mm if HIV infected or greater than 15 mm if HIV uninfected) for arms A and B only.
• Past history of treated MTB infection
• Known or underlying bleeding disorder (due to risk of bleeding from venipuncture)
• Psychiatric illness that might interfere with study compliance
• Use of immunomodulators (including corticosteroids and IL-2) or cytotoxic agents (including hydroxyurea) within 45 days of signing consent and at any time during study
• Small or difficult to access antecubital veins that make venipuncture difficult

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Mali

Bamako, Mali

Location

Related Publications (3)

• Ellner JJ. Review: the immune response in human tuberculosis--implications for tuberculosis control. J Infect Dis. 1997 Nov;176(5):1351-9. doi: 10.1086/514132. No abstract available.

  PMID: 9359738 BACKGROUND

• Orme IM, Andersen P, Boom WH. T cell response to Mycobacterium tuberculosis. J Infect Dis. 1993 Jun;167(6):1481-97. doi: 10.1093/infdis/167.6.1481.

  PMID: 8501346 BACKGROUND

• Sallusto F, Lenig D, Forster R, Lipp M, Lanzavecchia A. Two subsets of memory T lymphocytes with distinct homing potentials and effector functions. Nature. 1999 Oct 14;401(6754):708-12. doi: 10.1038/44385.

  PMID: 10537110 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sophia B Siddiqui, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: October 6, 2003
• Study Completion: November 27, 2015
• Last Updated: December 5, 2019

Record last verified: 2015-11-27

Locations

MA (1)