Immunity, HumoralCamzooNCT06680843
Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia
An observational study of Immunity, Humoral, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in Cambodia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity, Humoral
- What is being tested?
- Whole blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 5 sitesCambodia
- Study dates
- 1 Nov 2024to 1 May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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).
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Cambodia5 sites, 5 recruiting
- Recruiting
Communicable Disease Control Department
Battambang
Seng Heng, MD, 88512852782, senghengmoh@gmail.com
- Recruiting
Communicable Disease Control Department
Kampong Thom
Seng Heng, MD, 88512852782, senghengmoh@gmail.com
- Recruiting
Communicable Disease Control Department
Kampot
Seng Heng, MD, 88512852782, senghengmoh@gmail.com
- Recruiting
Communicable Disease Control Department
Stung Treng
Seng Heng, MD, 88512852782, senghengmoh@gmail.com
- Recruiting
Communicable Disease Control Department
Takeo
Seng Heng, MD, 88512852782, senghengmoh@gmail.com
About this study
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.
Read the 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
- Being tested
- Whole blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood collectionProcedure or surgery
30 mL at Day 0 with optional visits for up to 2 additional whole blood collections at least 30 days apart
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
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
Measured: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
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)
Measured: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity, HumoralStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christina Yek, MD, Principal investigator, NIH/NIAID/Laboratory of Malaria and Vector Research (LMVR)Lon Chanthap, MD, Principal investigator, Malaria Vector & Research Laboratory (MVRL) International Center of Excellence in Research CambodiaLy Sovann, MD, MTCM, Principal investigator, Cambodian Center for Communicable Disease (CCDC) Ministry of Health, Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680843
- Sponsor's protocol ID
- 002014
- Acronym
- Camzoo
- Status last verified
- May 2026
- First submitted
- 6 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested from other researchers 5 years following completion of the primary endpoint by contacting the Principal Investigators.