Immune Responses to Mycobacterium Tuberculosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00340990 |
Recruitment Status
:
Completed
First Posted
: June 21, 2006
Last Update Posted
: April 24, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
Mycobacterium Tuberculosis |
Study Type : | Observational |
Actual Enrollment : | 111 participants |
Official Title: | Pilot Study of CD4+ T Cell Immune Responses to Mycobacterium Tuberculosis |
Study Start Date : | October 6, 2003 |
Study Completion Date : | November 27, 2015 |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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).
CATEGORY-SPECIFIC MTB INCLUSION CRITERIA:
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
EXCLUSION CRITERIA:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340990
Mali | |
University of Mali | |
Bamako, Mali |
Principal Investigator: | Sophia B Siddiqui, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00340990 History of Changes |
Other Study ID Numbers: |
999904009 04-I-N009 |
First Posted: | June 21, 2006 Key Record Dates |
Last Update Posted: | April 24, 2018 |
Last Verified: | November 27, 2015 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Tuberculosis HIV CD4+ T Cell Interferon-Gamma Lymphocyte Proliferation |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |