NCT06850298

H5N1 Milk Detection Study

Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat. Inactive particles are not capable of causing disease. The results will help the Centers for Disease Control and Prevention (CDC) better understand how milk consumption could affect flu surveillance. Investigators also want to see if the body produces antibodies in response to this milk consumption.

Detailed description

Since March 2024, avian influenza A (H5N1) viruses have infected U.S. dairy cattle and spread widely. The virus has been identified in high concentrations in raw milk, and research shows that pasteurization - the process of heating milk to a specific temperature for a set time - inactivates the A (H5N1) virus. Therefore, the Food and Drug Administration (FDA) says that commercial pasteurized milk is safe for consumption. However, trace amounts of inactive influenza particles may still be detected in pasteurized milk. This study aims to determine whether drinking pasteurized milk could be a possible exposure for H5N1 influenza detection. The findings will support the Centers for Disease Control and Prevention's (CDC) efforts to evaluate milk consumption as a factor in influenza surveillance and provide context for interpreting surveillance data. Healthy adults will drink 250 mL of pasteurized milk containing the inactive H5N1 virus, provided by the CDC, either during a single visit or over three consecutive daily visits. Nasal and combined nasal/oral swabs will be collected immediately following milk consumption to assess the presence of influenza. Additionally, a subset of participants will provide blood, saliva, and stool samples at the initial visit and again 21-30 days post-consumption.

Conditions

• Influenza

Interventions

Type	Name	Description
OTHER	Pasteurized milk contaminated with killed A(H5) virus	Milk to be used in the study will be obtained from the CDC. Pasteurized commercial milk likely to contain detectable A(H5N1) particles will be obtained from a source such as a recently affected dairy farm. The CDC Influenza Division laboratory (Viral, Surveillance, and Diagnosis Branch) will test the milk to confirm the presence of viral A(H5) RNA using a protocol developed and validated by the US FDA Agricultural Research Service. The US Food and Drug Administration (FDA) has indicated that the consumption of commercial pasteurized dairy products in the US is safe.

Timeline

• Start date: 2025-05-09
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-02-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States