Immune System
Conditions
Keywords
Healthy Immune System
Brief summary
The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.
Detailed description
The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's instructions for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.
Interventions
BIOLOGICALEndotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\ 5 minutes)
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study. * Written informed consent prior to the performance of any study related procedure.
Exclusion criteria
* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension * Recent history of alcohol or drug abuse * Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures * Exposure to any experimental agent or procedure within 30 days of study * Pregnancy or breast feeding * Prior exposure to endotoxin in an experimental setting -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physiological, Hematological, Immunological Responses | .5-24 hours after Endotoxin administration |
Countries
United States
Outcome results
None listed