Do inactive H5N1 particles in pasteurized milk show up on nasal or throat tests?
Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens
NA · Emory University · NCT06850298
This study will test whether healthy adults who drink pasteurized milk containing killed H5N1 virus have the virus detected in nasal or throat swabs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06850298 on ClinicalTrials.gov |
What this trial studies
Researchers will give healthy adults 250 mL of pasteurized milk containing inactivated A(H5) virus provided by the CDC, either in a single visit or across three consecutive daily visits, and collect nasal and combined nasal/oral swabs immediately after consumption to look for viral material. A subset of participants will provide blood, saliva, and stool samples at the initial visit and again 21–30 days later to check for antibody responses. The protocol uses pasteurized milk with inactivated virus because pasteurization inactivates H5N1, but trace inactive particles may still be present and detectable. Results are intended to help interpret influenza surveillance data when viral material is found in people who consumed milk.
Who should consider this trial
Good fit: Healthy adults aged 18–64 years with BMI ≤ 35 kg/m2 who can consent, are not pregnant or breastfeeding, have no recent respiratory illness, and have no milk allergy are the intended participants.
Not a fit: People who are immunocompromised, pregnant or breastfeeding, allergic to milk, have recent respiratory symptoms, or otherwise meet exclusion criteria would not be eligible and would not gain benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help public health agencies interpret positive influenza detections after milk consumption and reduce misclassification of exposure in surveillance data.
How similar studies have performed: Direct feeding of inactivated influenza in pasteurized milk to test surveillance detection is a novel approach, though prior work shows raw milk can contain H5N1 and pasteurization inactivates the virus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18-64 years * BMI ≤ 35 kg/m2 * Able to understand and give informed consent (American English) and comply with study visits and procedures. * In good general health based on medical history and the investigator's clinical judgment. Exclusion Criteria: * Symptoms of acute respiratory illness or conjunctivitis within 7 days * Febrile illness in the previous 72 hours * Recent influenza antiviral use (within 14 days) * Immunosuppression due to illness or medications * Current pregnancy or breastfeeding * History of allergy or intolerance to milk or milk alternatives * Consumption of raw (unpasteurized) milk within the previous 14 days * Recent work (within 14 days) on a farm with animals known to be infected with A(H5) virus * Previous receipt of A(H5) vaccine at any time
Where this trial is running
Atlanta, Georgia
- Hope Clinic — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Graciaa, MD, MPH, MSc — Emory University
- Study coordinator: Daniel Graciaa, MD, MPH, MSc
- Email: dsgraci@emory.edu
- Phone: 404-712-1370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Influenza, Pasteurized Milk, Flu Virus A, H5N1 avian influenza A