Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

NCT ID: NCT06680843

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-05-01

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.

Conditions

Immunity, Humoral

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Whole blood collection

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Yek, MD

Role: PRINCIPAL_INVESTIGATOR

NIH/NIAID/Laboratory of Malaria and Vector Research (LMVR)

Lon Chanthap, MD

Role: PRINCIPAL_INVESTIGATOR

Malaria Vector & Research Laboratory (MVRL) International Center of Excellence in Research Cambodia

Ly Sovann, MD, MTCM

Role: PRINCIPAL_INVESTIGATOR

Cambodian Center for Communicable Disease (CCDC) Ministry of Health, Cambodia

Locations

Communicable Disease Control Department

Battambang, , Cambodia

Site Status: RECRUITING

Communicable Disease Control Department

Kampong Thom, , Cambodia

Site Status: RECRUITING

Communicable Disease Control Department

Kampot, , Cambodia

Site Status: RECRUITING

Communicable Disease Control Department

Stung Treng, , Cambodia

Site Status: RECRUITING

Communicable Disease Control Department

Takeo, , Cambodia

Site Status: RECRUITING

Countries

Cambodia

Central Contacts

Chanthap Lon, MD

Role: CONTACT

lonc@icercambodia.org

85512976799

Facility Contacts

Seng Heng, MD

Role: primary

senghengmoh@gmail.com

88512852782

Seng Heng, MD

Role: primary

senghengmoh@gmail.com

88512852782

Seng Heng, MD

Role: primary

senghengmoh@gmail.com

88512852782

Seng Heng, MD

Role: primary

senghengmoh@gmail.com

88512852782

Seng Heng, MD

Role: primary

senghengmoh@gmail.com

88512852782

Other Identifiers

002014

Identifier Type: -

Identifier Source: org_study_id