InflammationNCT00397280
Immune Cell Response to Stimuli
An observational study of Inflammation, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2009to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any healthy donors meeting inclusion/exclusion criteria
Who may be able to join
- 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)*
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- 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)
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
NIEHS Join A Study Recruitment Group, 855-696-4347, myniehs@nih.gov
About this study
Official title: Innate Immunity Signal Transduction in Human Leukocytes
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.
Read the detailed description
The objective of this study is several-fold. We wish to determine the response of white blood cells (neutrophils, monocytes, eosinophils, lymphocytes) to various signals in the test tube, to test how they sense the signals in the body, and what substances they produce. We wish to determine how these cells may, under certain circumstances, contribute to inflammation. We wish to measure the substances in the blood plasma that might contribute to stimulation of white blood cells to understand the response of the whole blood to potential disease-associated conditions.
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. Adult (18-65 yrs. old), nonpregnant, healthy volunteers will have 320 ml of whole blood collected by venipuncture in a monitored setting no more frequently than once every 8 weeks. No further interventions will be exercised upon the subjects. The whole blood will be fractionated into neutrophil, red blood cell, mononuclear cell, and plasma fractions using plasma-Percoll discontinuous centrifugation. Leukocytes will be subjected in vitro to inflammatory stimuli (e.g., LPS), and selected signaling outcomes (e.g., mitogen-activated protein kinase activation, Rho GTPase activation, protein-protein interactions) and functional measures (e.g., chemotaxis, superoxide anion and cytokine production) quantified in the absence and presence of relevant chemical inhibitors (e.g., SB203580, a p38 MAPK inhibitor). In each such experiment, cells from the daily donor will be used as paired controls to the in vitro experimental intervention (e.g., SB203580 inhibitor vs. DMSO vehicle). Three or more repetitions (on different donors) of each specific experimental outcome, as necessary, will be performed to establish statistical significance of findings.
A specific focus of the studies planned will be to define the role of lipid raft membrane microdomains in transduction of the LPS signal in human leukocytes. Lipid rafts are cholesterol-rich microdomains in the plasma membrane, within which the LPS receptor, Toll-like Receptor 4 (TLR4), has been described to reside. LPS signaling has been reported to be sensitive to raft cholesterol content, presumably because the specific repertoire of proteins in rafts is sensitive to raft cholesterol content. Rafts are thought to act as dynamic signaling platforms for co-segregation of proximal adaptor proteins, kinases, and other signaling proteins. Of interest, while LPS has been described to modulate the activity of proteins that determine raft cholesterol content (egg, Liver X Receptor, ABCA1), virtually no work has been done to clarify: 1) the mechanisms underlying LPS-induced intracellular cholesterol redistribution, and, more importantly, 2) whether such intracellular redistribution of cholesterol is causal to the signaling events triggered by LPS, or 3) whether innate immunity signaling is dependent upon inter-subject variations in raft cholesterol content.
Furthermore, we will investigate the role of the tumor suppressor gene p53 in the regulation of inflammation. It is now widely accepted that inflammation and cancer development are interconnected. Dr. Menendez is one of the international leaders in the study of the tumor suppressor gene p53. His group has discovered that activation of p53 through exposure to carcinogenic stimuli leads to differential expression of genes that have a direct effect on the inflammatory response, such as several toll-like-receptor genes. Dr. Menendez will use human leukocytes that will be isolated from whole blood. He will expose these cells to stimuli that activate p53, such as doxorubicin (a chemotherapy agent) or radiation, and examine the expression of toll-like-receptor genes as well as the response to LPS and other inflammatory agents in vitro.
Finally, we will investigate the role of zinc-finger proteins in gene expression in inflammatory cells. ZFP36 is an RNA binding zinc finger protein that is involved in the turnover of mRNAs encoding several clinical important cytokines, including TNFa. Several missense, promoter and 3'-untranslated variants have been identified in humans; in some cases, these variants and their haplotypes have been associated with human inflammatory disease. We will isolate peripheral blood macrophages and stimulate them with LPS and other cytokines, then evaluate the behavior of cytokine mRNA and gene expression.
- Conditions
- Inflammation
- Keywords
- Inflammatory Response, Lipopolysaccharide, Natural History
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Any healthy donors meeting inclusion/exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: analysis of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study start13 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael B Fessler, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397280
- Sponsor's protocol ID
- 070023
- Other IDs
- 07-E-0023
- Status last verified
- 27 Feb 2026
- First submitted
- 8 Nov 2006
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It isn t known yet if there will be a plan to make IPD available
Publications
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.
PubMed 15908399Fessler 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.
PubMed 15262974Frasch 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.
PubMed 14766753
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity Signal Transduction in Human Leukocytes
- ClinicalTrials.gov ID
- NCT00397280
- Acronym / sponsor ID
- 070023
- Conditions
- Inflammation
- Keywords
- Inflammatory Response, Lipopolysaccharide, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 13 Jul 2009 (actual)
- First posted
- 9 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is several-fold. We wish to determine the response of white blood cells (neutrophils, monocytes, eosinophils, lymphocytes) to various signals in the test tube, to test how they sense the signals in the body, and what substances they produce. We wish to determine how these cells may, under certain circumstances, contribute to inflammation. We wish to measure the substances in the blood plasma that might contribute to stimulation of white blood cells to understand the response of the whole blood to potential disease-associated conditions.
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. Adult (18-65 yrs. old), nonpregnant, healthy volunteers will have 320 ml of whole blood collected by venipuncture in a monitored setting no more frequently than once every 8 weeks. No further interventions will be exercised upon the subjects. The whole blood will be fractionated into neutrophil, red blood cell, mononuclear cell, and plasma fractions using plasma-Percoll discontinuous centrifugation. Leukocytes will be subjected in vitro to inflammatory stimuli (e.g., LPS), and selected signaling outcomes (e.g., mitogen-activated protein kinase activation, Rho GTPase activation, protein-protein interactions) and functional measures (e.g., chemotaxis, superoxide anion and cytokine production) quantified in the absence and presence of relevant chemical inhibitors (e.g., SB203580, a p38 MAPK inhibitor). In each such experiment, cells from the daily donor will be used as paired controls to the in vitro experimental intervention (e.g., SB203580 inhibitor vs. DMSO vehicle). Three or more repetitions (on different donors) of each specific experimental outcome, as necessary, will be performed to establish statistical significance of findings.
A specific focus of the studies planned will be to define the role of lipid raft membrane microdomains in transduction of the LPS signal in human leukocytes. Lipid rafts are cholesterol-rich microdomains in the plasma membrane, within which the LPS receptor, Toll-like Receptor 4 (TLR4), has been described to reside. LPS signaling has been reported to be sensitive to raft cholesterol content, presumably because the specific repertoire of proteins in rafts is sensitive to raft cholesterol content. Rafts are thought to act as dynamic signaling platforms for co-segregation of proximal adaptor proteins, kinases, and other signaling proteins. Of interest, while LPS has been described to modulate the activity of proteins that determine raft cholesterol content (egg, Liver X Receptor, ABCA1), virtually no work has been done to clarify: 1) the mechanisms underlying LPS-induced intracellular cholesterol redistribution, and, more importantly, 2) whether such intracellular redistribution of cholesterol is causal to the signaling events triggered by LPS, or 3) whether innate immunity signaling is dependent upon inter-subject variations in raft cholesterol content.
Furthermore, we will investigate the role of the tumor suppressor gene p53 in the regulation of inflammation. It is now widely accepted that inflammation and cancer development are interconnected. Dr. Menendez is one of the international leaders in the study of the tumor suppressor gene p53. His group has discovered that activation of p53 through exposure to carcinogenic stimuli leads to differential expression of genes that have a direct effect on the inflammatory response, such as several toll-like-receptor genes. Dr. Menendez will use human leukocytes that will be isolated from whole blood. He will expose these cells to stimuli that activate p53, such as doxorubicin (a chemotherapy agent) or radiation, and examine the expression of toll-like-receptor genes as well as the response to LPS and other inflammatory agents in vitro.
Finally, we will investigate the role of zinc-finger proteins in gene expression in inflammatory cells. ZFP36 is an RNA binding zinc finger protein that is involved in the turnover of mRNAs encoding several clinical important cytokines, including TNFa. Several missense, promoter and 3'-untranslated variants have been identified in humans; in some cases, these variants and their haplotypes have been associated with human inflammatory disease. We will isolate peripheral blood macrophages and stimulate them with LPS and other cytokines, then evaluate the behavior of cytokine mRNA and gene expression.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Any healthy donors meeting inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any healthy donors meeting inclusion/exclusion criteria
Key inclusion criteria (9 listed)
- 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)*
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 15908399Walker 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.
- Background: PubMed 15262974Fessler 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.
- Background: PubMed 14766753Frasch 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It isn t known yet if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Fessler, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NIEHS Join A Study Recruitment Group ((855) 696-4347, myniehs@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.