Sample Collection From Healthy Volunteers for Assay Optimization

StatusRecruiting
PhaseNot specified
Started

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Record History

The 50 most recent of 215 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Minor Eligibility criteria expanded, about 26 words
  4. 23 versions Re-verified since Jun 14, 2025, no change to tracked fieldsv190-v212
  5. Minor Eligibility criteria shortened, about 7 wordsv189
Show 23 earlier versionsHide 23 earlier versions
  1. 20 versions Re-verified since Nov 28, 2024, no change to tracked fieldsv169-v188
  2. Notable Primary and study completion dates: Jun 30, 2027 to Jun 30, 2043
    • Eligibility criteria revised
    v168
  3. Study Status, Eligibilityv167
  4. Re-verified, no change to tracked fieldsv166
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available. Objective: To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs. Eligibility: Healthy people ages 3-80 Design: Participants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests. If the results of the screening are normal, participants will be asked to give one or more of these samples: Blood will be drawn from an arm vein with a needle and syringe. Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina. Participants will spit into a tube to collect saliva. Participants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions. Over the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour. About every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.
Trial Details
NCT Number NCT03538600
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)
Healthy Volunteers
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov