Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

Last updated: November 6, 2024
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Whole blood collection

Clinical Study ID

NCT06680843
002014
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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:

  4. Hunting, slaughtering, or consuming suspected infected animals;

  5. Fruit collection, date palm sap harvesting, or tree pruning within agriculturalplantations containing bat roosts;

  6. Bat guano farming;

  7. Ancillary work in live animal markets or wild animal habitats identified aslikely containing infected animals (e.g., provision of cleaning,transportation, or tourism services);

  8. Living within 5 km of identified animal markets or wild animal habitatsidentified as likely containing infected animals.

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

Exclusion

Exclusion Criteria:

  1. Pregnancy (based on self-reporting).

  2. Any underlying, chronic, or current medical condition that, in the opinion of theinvestigator, would interfere with participation in the study (e.g., inability orgreat 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 assystolic blood pressure <90 mm Hg or diastolic blood pressure <50 mm Hg) present atscreening.

  5. Self-reported diagnosis of immune deficiency, including HIV infection, chroniccorticosteroid use (≥10 mg prednisone dose or its equivalent for a continuous periodof ≥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 ofstudy enrollment.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Whole blood collection
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
May 01, 2028

Study 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.

Connect with a study center

  • Communicable Disease Control Department

    Battambang,
    Cambodia

    Active - Recruiting

  • Communicable Disease Control Department

    Kampong Thom,
    Cambodia

    Active - Recruiting

  • Communicable Disease Control Department

    Kampot,
    Cambodia

    Active - Recruiting

  • Communicable Disease Control Department

    Stung Treng,
    Cambodia

    Active - Recruiting

  • Communicable Disease Control Department

    Takeo,
    Cambodia

    Active - Recruiting

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