Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia (NCT06680843) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia
Cambodia400 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antibody binding activity in plasma samples against known immunodominant zoonotic viral proteins
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
2
Neutralizing activity of plasma samples against known immunodominant zoonotic viral proteins
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
3
Isolate viral antigen-specific B cells for phenotyping and immunoglobulin sequencing
Timeframe: Day 0 and 2 optional visits at least 30 days apart between Day 180-720
Trial details
NCT IDNCT06680843
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Living within 5 km of identified animal markets or wild animal habitats identified as likely containing infected animals.
Exclusion criteria
. 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.