NCT01143480

Brief Summary

Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: \- To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design:

  • The study will involve one visit of 45 to 60 minutes.
  • Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking.
  • Participants will provide a blood sample for research purposes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
725

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 30, 2012

Completed
Last Updated

June 11, 2026

Status Verified

March 17, 2026

First QC Date

June 11, 2010

Last Update Submit

June 10, 2026

Conditions

AsthmaAtherosclerosisMetabolic SyndromeCancerInsulin Resistance

Keywords

EndotoxinInnate ImmunityNatural HistoryHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • The primary endpoints of this study are for both cell types and will be levels of 6 cytokines [TNF alpha, IL-6, MIP-2, IL-8, MCP-1, and IFN-beta (ELISA)] induced by LPS and by PAM3CSK4 plus baseline cytokine levels (no exposure to LPS or PAM3CSK...

    The primary endpoints of this study are for both cell types and will be levels of 6 cytokines \[TNF alpha, IL-6, MIP-2, IL-8, MCP-1, and IFN-beta (ELISA)\] induced by LPS and by PAM3CSK4 plus baseline cytokine levels (no exposure to LPS or PAM3CSK4).

    After analysis

Study Arms (13)

ABCA1

SNP or allele of interest

APOE

SNP or allele of interest

APOL1

SNP or allele of interest

CD14

SNP or allele of interest

CD44

SNP or allele of interest

IRGM

SNP or allele of interest

ITIH3

SNP or allele of interest

ITIH4

SNP or allele of interest

MyD88

SNP or allele of interest

TIRAP

SNP or allele of interest

TLR4

SNP or allele of interest

TLR5

SNP or allele of interest

TNFa

SNP or allele of interest

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants enrolled in Environmental Polymorphism Registry (EPR)@@@

You may qualify if:

  • Male or female 18 years of age or older
  • Participants must be able to understand and provide written informed consent to participate in the study
  • Participants must be able to travel to the CRU
  • Willing and able to fast after midnight the night prior to their study appointment.
  • Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).

You may not qualify if:

  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)
  • Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit
  • Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)
  • Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)
  • Current treatment for cancer with chemotherapy or radiation
  • Confirmed or suspected immunosuppressive or immunodeficient condition
  • GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies
  • Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \>200 ng/mL at visit)
  • Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit
  • Body weight \< 50 kg (\<110 lbs)
  • Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or \> 170/95 mm Hg; pulse rate \< 50 or \>100 beats/minute
  • Pregnant or suspected pregnancy
  • Chronic Kidney Disease
  • The PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Publications (3)

  • Castiblanco J, Varela DC, Castano-Rodriguez N, Rojas-Villarraga A, Hincapie ME, Anaya JM. TIRAP (MAL) S180L polymorphism is a common protective factor against developing tuberculosis and systemic lupus erythematosus. Infect Genet Evol. 2008 Sep;8(5):541-4. doi: 10.1016/j.meegid.2008.03.001. Epub 2008 Mar 12.

    PMID: 18417424BACKGROUND

  • Singaraja RR, Brunham LR, Visscher H, Kastelein JJ, Hayden MR. Efflux and atherosclerosis: the clinical and biochemical impact of variations in the ABCA1 gene. Arterioscler Thromb Vasc Biol. 2003 Aug 1;23(8):1322-32. doi: 10.1161/01.ATV.0000078520.89539.77. Epub 2003 May 22.

    PMID: 12763760BACKGROUND

  • Kenny EF, O'Neill LA. Signalling adaptors used by Toll-like receptors: an update. Cytokine. 2008 Sep;43(3):342-9. doi: 10.1016/j.cyto.2008.07.010. Epub 2008 Aug 15.

    PMID: 18706831BACKGROUND

Related Links

MeSH Terms

Conditions

AsthmaAtherosclerosisMetabolic SyndromeInsulin ResistanceNeoplasms

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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) 696-4347myniehs@nih.gov

Michael B Fessler, M.D.

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

July 30, 2012

Last Updated

June 11, 2026

Record last verified: 2026-03-17

Locations

US(1)