Immune Cell Response to Stimuli

NCT00397280 | Recruiting

• 2 other identifiers: 07002307-E-0023
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Inflammatory Response; Lipopolysaccharide; Natural History

Outcome Measures

Primary Outcomes (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.

  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.

  analysis of the study

Study Arms (1)

1

Any healthy donors meeting inclusion/exclusion criteria

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any healthy donors meeting inclusion/exclusion criteria

You may qualify if:

• Normal, healthy adult donors as judged by screening questionnaire
• Nonpregnant
• Weighing at least 110 lbs
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Publications (3)

• Walker TS, Tomlin KL, Worthen GS, Poch KR, Lieber JG, Saavedra MT, Fessler MB, Malcolm KC, Vasil ML, Nick JA. Enhanced Pseudomonas aeruginosa biofilm development mediated by human neutrophils. Infect Immun. 2005 Jun;73(6):3693-701. doi: 10.1128/IAI.73.6.3693-3701.2005.

  PMID: 15908399 BACKGROUND

• Fessler MB, Arndt PG, Frasch SC, Lieber JG, Johnson CA, Murphy RC, Nick JA, Bratton DL, Malcolm KC, Worthen GS. Lipid rafts regulate lipopolysaccharide-induced activation of Cdc42 and inflammatory functions of the human neutrophil. J Biol Chem. 2004 Sep 17;279(38):39989-98. doi: 10.1074/jbc.M401080200. Epub 2004 Jul 15.

  PMID: 15262974 BACKGROUND

• Frasch SC, Henson PM, Nagaosa K, Fessler MB, Borregaard N, Bratton DL. Phospholipid flip-flop and phospholipid scramblase 1 (PLSCR1) co-localize to uropod rafts in formylated Met-Leu-Phe-stimulated neutrophils. J Biol Chem. 2004 Apr 23;279(17):17625-33. doi: 10.1074/jbc.M313414200. Epub 2004 Feb 6.

  PMID: 14766753 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Fessler, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Michael B Fessler, M.D.

CONTACT

(984) 287-4081; fesslerm@niehs.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: July 13, 2009
• Last Updated: March 24, 2026

Record last verified: 2026-02-27

Locations

US (1)