Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia (NCT06680843) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia
Cambodia400 participantsStarted 2024-11-01
Plain-language summary
This is a biospecimen procurement protocol to characterize the immune response to zoonotic virus exposure in healthy adult humans aged 18 to 65 years with high-risk exposure to animals or their excreta (e.g., guano farming and wet markets), or living within 5 km of animal habitats (e.g., bat caves and bat roosts) in Cambodia.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Capacity to provide informed consent.
✓. Adult aged 18-65 years.
✓. Have interaction with suspected infected animals within the last 2 years, including (but not limited to) the following risk factors:
✓. Hunting, slaughtering, or consuming suspected infected animals;
✓. Fruit collection, date palm sap harvesting, or tree pruning within agricultural plantations containing bat roosts;
✓. Bat guano farming;
✓. Ancillary work in live animal markets or wild animal habitats identified as likely containing infected animals (e.g., provision of cleaning, transportation, or tourism services);
✓. Living within 5 km of identified animal markets or wild animal habitats identified as likely containing infected animals.
Exclusion criteria
✕. Pregnancy (based on self-reporting).
✕. Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood, known anemia).
✕. Self-reported symptoms suggestive of acute infection (acute myalgias, arthralgias, headache, retro-orbital pain, dyspnea, rash) within 7 days prior to enrollment.
✕
What they're measuring
1
Antibody binding activity in plasma samples against known immunodominant zoonotic viral proteins
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
2
Neutralizing activity of plasma samples against known immunodominant zoonotic viral proteins
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
3
Isolate viral antigen-specific B cells for phenotyping and immunoglobulin sequencing
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
Trial details
NCT IDNCT06680843
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Signs suggestive of acute infection (fever, defined as internal temperature \>38°C; hypoxemia, defined as peripheral oxygen saturation of \<90%; hypotension, defined as systolic blood pressure \<90 mm Hg or diastolic blood pressure \<50 mm Hg) present at screening.
✕. Self-reported diagnosis of immune deficiency, including HIV infection, chronic corticosteroid use (≥10 mg prednisone dose or its equivalent for a continuous period of ≥30 days within the last 1 year), ongoing or prior (within the last 10 years) receipt of chemotherapy or immunotherapy, or current hematological malignancy.
✕. Receipt of blood products, including immunoglobulin products, within 120 days of study enrollment.