Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

ClinicalTrials.gov ID

NCT06680843

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

Overall Status

Recruiting

Study Type

Observational

Enrollment

400Estimated

Last Update Posted

May 6, 2026Actual

Start Date

Nov 1, 2024Actual

Primary Completion Date

Oct 31, 2027Estimated

Completion Date

May 1, 2028Estimated

Official Title

Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

Brief 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.

Detailed Description

This is a biospecimen procurement protocol to characterize immune signatures to zoonotic virus exposure in healthy adult humans aged 18 to 65 years who handle suspected infected animals or their excreta, or living within 5 km of animal reservoirs, in Cambodia.

The primary study objective is to characterize immunity to zoonotic viruses, specifically H5N1. To meet this objective, when possible, individuals with the highest likelihood of prior exposure to the viruses of interest (Nipahvirus, bCoVs, H5N1) will be screened for study inclusion. These high-exposure risk behaviors include direct handling of known or suspected infected animals or their excreta. If insufficient individuals meeting these criteria are found, then sampling will include individuals with lower risk exposures, including living or working in areas proximal to (within 5 km of) animal habitats.

All human subjects research activities will be conducted by study personnel within the International Center of Excellence in Research Cambodia, Cambodian CCDC, and the Forestry Administration of the Royal Government of Cambodia. NIH investigators are involved in study design, implementation, analysis of coded samples and data, and writing and dissemination of reports of study results. Although they may support Cambodian investigators in monitoring/oversight capacities, NIH investigators will not be engaged in human subjects research.

• Immunity, Humoral

• Whole blood collection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Capacity to provide informed consent.

2. Adult aged 18-65 years.

3. Have interaction with suspected infected animals within the last 2 years, including (but not limited to) the following risk factors:

   1. Hunting, slaughtering, or consuming suspected infected animals;
   2. Fruit collection, date palm sap harvesting, or tree pruning within agricultural plantations containing bat roosts;
   3. Bat guano farming;
   4. 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);
   5. Living within 5 km of identified animal markets or wild animal habitats identified as likely containing infected animals.

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

Exclusion Criteria:

1. Pregnancy (based on self-reporting).
2. 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).
3. Self-reported symptoms suggestive of acute infection (acute myalgias, arthralgias, headache, retro-orbital pain, dyspnea, rash) within 7 days prior to enrollment.
4. 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.
5. 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.
6. Receipt of blood products, including immunoglobulin products, within 120 days of study enrollment.

Observational Model

Ecologic or Community

Time Perspective

Cross-Sectional

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

senghengmoh@gmail.com88512852782

senghengmoh@gmail.com88512852782

senghengmoh@gmail.com88512852782

senghengmoh@gmail.com88512852782

• Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers

  NCT04594395

  WithdrawnObservationalUpdated Oct 4, 2021
• Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing

  NCT04034264

  RecruitingObservationalUpdated Sep 1, 2026
• Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia

  NCT04350905

  CompletedInterventionalPhase 1Updated Apr 12, 2022
• Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia

  NCT04434846

  CompletedObservationalUpdated Apr 26, 2024
• Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective

  NCT07358910

  RecruitingObservationalUpdated Jan 22, 2026
• Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo

  NCT04012164

  CompletedInterventionalNot ApplicableUpdated Mar 27, 2024