Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

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 volunteers

Qualifiers

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

Design model

Ecologic or community

Time perspective

Cross-sectional

Treatments tested in this trial

  • Whole blood collection

    Procedure/Surgery

    30 mL at Day 0 with optional visits for up to 2 additional whole blood collections at least 30 days apart

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
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

Measured by circulating antigen-specific B cells constituting approximately 0.001%-0.005% total PBMCs

Time frame
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

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)

Time frame
Day 0 and 2 optional visits at least 30 days apart between Day 180-720

Secondary outcomes

Other outcomes

Sponsors and contacts

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