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Immune Cell Response to Stimuli

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ClinicalTrials.gov Identifier: NCT00397280
Recruitment Status : Recruiting
First Posted : November 9, 2006
Last Update Posted : June 17, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Brief Summary:

This study will investigate the response of immune cells (neutrophils, monocytes) to various signals in the test tube to determine how they sense the signals in the body and what substances they produce in response to them. It will determine how the cells may, under certain circumstances, contribute to inflammation, and will measure substances in the blood plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells, in order to understand how the blood responds to possible disease-related conditions.

Healthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1/3 cups) or less at each donation. They donate no more than once every 8 weeks and no more than six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected blood is separated into its components and specific cells are exposed to substances to examine their response.


Condition or disease
Inflammation

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 2040 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Innate Immunity Signal Transduction in Human Leukocytes
Actual Study Start Date : July 13, 2009

Group/Cohort
1
Any healthy donors meeting inclusion/exclusion criteria



Primary Outcome Measures :
  1. The objective is to define the signaling pathways activated by lipopolysaccharide (LPS) and other selected innate immunity stimuli, and the downstream inflammatory functional consequences, in human leukocytes in vitro. [ Time Frame: analysis of the study ]
    The objective is to define the signaling pathways activated by lipopolysaccharide (LPS) and other selected innate immunity stimuli, and the downstream inflammatory functional consequences, in human leukocytes in vitro.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any healthy donors meeting inclusion/exclusion criteria
Criteria
  • INCLUSION CRITERIA:
  • Normal, healthy adult donors as judged by screening questionnaire
  • Nonpregnant
  • Weighing at least 110 lbs
  • 18-65 years of age
  • HIV negative (proof required every 6 months we will conduct test)*
  • Hepatitis B surface antigen and hepatitis C serology negative (checked every 6 months we will conduct test)*

    • The rationale for HIV and hepatitis viral testing is that chronic viral infection may alter and possibly invalidate our experimental results. HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory and will be paid for by the study group. Results will be available only to the study doctor/PI (Fessler), the study coordinator, the CRU Director (Garantziotis, LAI), and the donor, with the few caveats that follow

All positive HIV, hepatitis B, and hepatitis C results will be promptly communicated to the donor by the study doctor/PI or the CRU Director. The participant will be referred to their physician and/or to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and/or hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and/or hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results.

HIV and hepatitis B/C test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room.In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B/C and HIV Notification Process for Reactive Results Form)

EXCLUSION CRITERIA:

By questionnaire:

Feeling ill within the last 24 hours.

Alcohol consumption in the last 24 hours.

Visit to the dentist in the last 24 hours.

A doctor visit for illness or vaccination in the last 2 weeks.

Diarrhea in the last 2 weeks.

Recurrent fever (4 weeks).

Pregnant or suspected pregnancy in the last 6 weeks.

Blood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks.

Receiving a blood donation in the past 12 months.

Bleeding disorder.

Anemia.

Heart problems.

Insulin dependent diabetes.

Problems with blood donation.

Risk of or evidence of Creutzfeldt-Jacob Disease in the family.

HIV-positive status, Hepatitis B/C-positive status or other confirmed or suspected immunosuppressive or immunodeficient conditions.

Use of immunosuppressants or other immune-modifying drugs.

Use of selected medications within the preceding 5 days unless the PI or AI receiving the samples states otherwise (NSAIDS/aspirin/tylenol, antidepressants, antihistamines , corticosteroids, HMG CoA reductase inhibitors, and antihypertensives).

By exam:

Temperature over 99.5 F.

Blood pressure less than 90/50.

Blood pressure higher than 170/95 mm Hg.

Pulse rate less than 50 or greater than 100 beats/minute.

If blood donation exceeds 200ml:

  • Hematocrit less than 34% for women or less than 36% for men, or greater than 56% for either gender.
  • Patients will be informed of disqualifying vital signs and hematocrit values and advised by trained staff, as appropriate, to seek assistance from their physician.

Information from the National Library of Medicine

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): NCT00397280


Contacts
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Contact: NIEHS Join A Study Recruitment Group (855) 696-4347 myniehs@nih.gov
Contact: Michael B Fessler, M.D. (984) 287-4081 fesslerm@niehs.nih.gov

Locations
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United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States
Contact: Lisa Murphy    919-541-9839    murphylb@mail.nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Michael B Fessler, M.D. National Institute of Environmental Health Sciences (NIEHS)
Additional Information:
Publications:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00397280    
Other Study ID Numbers: 070023
07-E-0023
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: June 17, 2021
Last Verified: June 8, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Inflammatory Response
Lipopolysaccharide
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes