This study is currently recruiting participants.
Number
04-I-0266
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 65 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Cerebrospinal Fluid; Stool; Urine; Natural History; Skin; Sputum
Recruitment Keyword(s)
Healthy Volunteer; HV
Condition(s)
Healthy Volunteer
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65.
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Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB(2) and the Code of Federal Regualtions 21 CFR 640(3). Specific criteria follow: INCLUSION CRITERIA (blood, urine, stool and/or sputum donation): -ability to sign informed consent -healthy, male or female -18-85 years of age EXCLUSION CRITERIA (blood, urine, stool and/or sputum donation): -pregnancy -weight <110 pounds -history of heart, lung, kidney disease, chronic anemia or bleeding disorders Eligibility criteria for volunteer bone marrow, skin and cerebrospinal fluid donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study: INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation): -ability to sign informed consent -healthy, male or female -18-85 years of age -willingness to provide concurrent blood sample EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation): -a known bleeding disorder, low platelets (<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal antiinflammatory agents or warfarin -anemia (hemoglobin less than 12.3 mg/dL) -evidence of an immune deficiency, such as HIV infection or cancer -pregnancy -taking a medication that affects the immune response within the past month, including oral, intravenous, or injectable steroids -allergic to xylocaine -have taken an investigational drug in the last 6 months -any other medical condition that the investigator feels puts the participant at too high a risk for participation *warfarin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If warfarin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is < 15.5 seconds and the PTT is within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7- day washout period will be required before bone marrow sampling, skin biopsy or lumbar puncture. Additonal exclusion criteria (cerebrospinal fluid): -Previous diagnosis of central nervous system pathology (including tumors, inflammatory conditions, infection, seizure disorder, spina bifida) -History of spinal surgery with hardware placement -History of any spinal surgery or injections of the lumbosacral spine -Headache on the day of donation Additonal exclusion criteria (skin biopsy): -History of keloid or abnormal scar formation
INCLUSION CRITERIA (blood, urine, stool and/or sputum donation):
-ability to sign informed consent
-healthy, male or female
-18-85 years of age
EXCLUSION CRITERIA (blood, urine, stool and/or sputum donation):
-pregnancy
-weight <110 pounds
-history of heart, lung, kidney disease, chronic anemia or bleeding disorders
Eligibility criteria for volunteer bone marrow, skin and cerebrospinal fluid donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study:
INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):
-willingness to provide concurrent blood sample
EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):
-a known bleeding disorder, low platelets (<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal antiinflammatory agents or warfarin
-anemia (hemoglobin less than 12.3 mg/dL)
-evidence of an immune deficiency, such as HIV infection or cancer
-taking a medication that affects the immune response within the past month, including oral, intravenous, or injectable steroids
-allergic to xylocaine
-have taken an investigational drug in the last 6 months
-any other medical condition that the investigator feels puts the participant at too high a risk for participation
*warfarin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If warfarin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is < 15.5 seconds and the PTT is within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7- day washout period will be required before bone marrow sampling, skin biopsy or lumbar puncture.
Additonal exclusion criteria (cerebrospinal fluid):
-Previous diagnosis of central nervous system pathology (including tumors,
inflammatory conditions, infection, seizure disorder, spina bifida)
-History of spinal surgery with hardware placement
-History of any spinal surgery or injections of the lumbosacral spine
-Headache on the day of donation
Additonal exclusion criteria (skin biopsy):
-History of keloid or abnormal scar formation
Principal Investigator
Referral Contact
For more information: