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Protocol Details

Innate Immunity Signal Transduction in Human Leukocytes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Environmental Health Sciences (NIEHS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)



Inflammatory Response;
Natural History

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Environmental Health Sciences

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.

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- 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)


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.


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.

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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.

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. Epub 2004 Jul 15.

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. Epub 2004 Feb 6.

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Principal Investigator

Referral Contact

For more information:

Michael B. Fessler, M.D.
National Institute of Environmental Health Sciences (NIEHS)
(984) 287-4081

NIEHS Join A Study Recruitment Group
National Institute of Environmental Health Sciences (NIEHS)

(855) 696-4347

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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