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Immune Modulation clinical trials

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NCT ID: NCT03084614 Terminated - Tuberculosis Clinical Trials

CD8 Reactivity to Microorganisms in Blood and Breast Milk

Start date: March 28, 2017
Phase:
Study type: Observational

Background: When a person is exposed to something that causes an infection, the body sends a type of cell called CD8 T cells to attack it. Those cells are also found in breast milk. Nursing mothers pass these cells to their child, which helps the child fight infections, too. Researchers want to learn more about how CD8 cells work to keep people healthy. Objective: To learn more about how the human body fights off infections. Eligibility: People age 18 years and older who either have an infection, are suspected to have an infection, or recently got a vaccine. The household contacts of these people and people who have not been recently exposed to any infection are also needed. Design: Participants will be screened with a medical and health history and physical exam. They may have blood tests. The first study visit can be the same day as screening. It can be up to 3 months later. For those visits, screening tests will be repeated. At the first visit, participants will have blood collected from an arm vein. Participants who are breastfeeding may provide a small sample of breast milk. They may collect it at home or bring a pumping device to NIH to collect it. NIH can also provide a breast pump. Participants may be contacted for up to 1 year after the first visit to give samples of blood and/or breast milk. Up to 4 additional visits, which will each take about 1 hour, may be scheduled. A personal physician or local lab can collect blood from participants and ship it to NIH. Breast milk cannot be shipped.

NCT ID: NCT02025660 Completed - Septic Shock Clinical Trials

Efficacy of Mw Vaccine in Treatment of Severe Sepsis

MISS
Start date: August 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis. Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following - Mortality in the two arms - Daily SOFA scores - Ventilator free days - Time-to-vasopressor withdrawal - ICU length of stay - Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care

NCT ID: NCT01200836 Completed - Healthy Volunteers Clinical Trials

Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol

Start date: July 1, 2010
Phase:
Study type: Observational

Background: - The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect the immune system and reduce inflammation, but the reason for this effect is unclear. Researchers are interested in testing the effect of rosuvastatin on the immune systems of healthy volunteers with good cholesterol levels. Objectives: - To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers. Eligibility: - Healthy individuals at least 18 years of age who have an acceptable blood level of LDL cholesterol (below 160). Design: - Participants will be screened with a medical history and physical examination, as well as blood tests to check general health, cholesterol levels, liver function, and the C-reactive protein (which responds to inflammation). - Participants will not be permitted to take most prescription and over-the-counter medications that affect the immune system, including antihistamines and certain pain relievers. For 1 week before the study, participants will have a wash-out period without any of these medications. - Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure consistent blood sample results). - Participants will provide blood samples at the following time points: (1) immediately before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3) after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.