RecruitingNCT06680843

Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

400 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Immunity, Humoral

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

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.
Willing to allow biological samples and data to be stored for future research.

Exclusion Criteria6

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.
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.

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Interventions

PROCEDUREWhole blood collection

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