H5N1 Milk Detection Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza
• Intervention / Treatment: Other: Pasteurized milk contaminated with killed A(H5) virus

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Graciaa, MD, MPH, MSc; Phone Number: 404-712-1370; Email: dsgraci@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Hope Clinic
      • Principal Investigator: Daniel Graciaa, MD
      • Contact: Daniel Graciaa, MD, MPH, MSc; Phone Number: 404-712-1370; Email: dsgraci@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Day Group; Participants will consume 250 mL of pasteurized commercial milk at a study visit.	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.
Experimental: 3-Day Group; Participants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of respiratory specimens with influenza detected	Proportion of respiratory specimens (nasopharyngeal and combined nasal/oropharyngeal swabs) with detection of influenza after consumption of pasteurized milk contaminated with killed A(H5) virus	Up to 30 days after milk consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe adverse events after milk consumption	Participants will be asked to call the site if they develop any adverse events for the entire the study participation.	Up to 30 days after milk consumption

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Daniel Graciaa, MD, MPH, MSc, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pasteurized Milk; Flu Virus A (H5); H5N1 avian influenza A
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: STUDY00009067; 75N93021C00017-P00012-9999-5 (U.S. NIH Grant/Contract); 2025P010412 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will share deidentified respiratory testing results.
• IPD Sharing Time Frame: The team will share the data immediately following the study publication, or at the end of the study analysis if not published, with no end date.
• IPD Sharing Access Criteria: Data will be available for access in a public database such as Dataverse.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No