About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Capacity to provide informed consent.
Adult aged 18-65 years.
Hunting, slaughtering, or consuming suspected infected animals;
Fruit collection, date palm sap harvesting, or tree pruning within agricultural plantations containing bat roosts;
Disqualifiers
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.
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.
Trial population
Healthy adults aged 18 to 65 years who handle suspected infected animals or their excreta, or living within 5 km of animal reservoirs, in Cambodia (n=160 to 320).
Trial design
Ecologic or community
Cross-sectional
Treatments tested in this trial
Whole blood collection
Procedure/Surgery30 mL at Day 0 with optional visits for up to 2 additional whole blood collections at least 30 days apart
Treatment groups
Trial outcomes
Primary outcomes
Antibody binding activity in plasma samples against known immunodominant zoonotic viral proteins
Measured by binding antibody titer greater than cutoffs established from healthy U.S. donors (3 standard deviations above mean signal intensity) to a panel of either henipaviruses, influenza viruses, or sarbecoviruses
Neutralizing activity of plasma samples against known immunodominant zoonotic viral proteins
Measured by circulating antigen-specific B cells constituting approximately 0.001%-0.005% total PBMCs
Isolate viral antigen-specific B cells for phenotyping and immunoglobulin sequencing
Measured by isolation of an expected 20 million PBMCs from whole blood samples, yielding approximately 100-500 antigen-specific B cells for single-cell B-cell sequencing (anticipated cell death up to 50% during the isolation and sorting process)
Sponsors and contacts
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