H5N1 Milk Detection Study

NCT ID: NCT06850298

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-09
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1-Day Group

Participants will consume 250 mL of pasteurized commercial milk at a study visit.

Group Type: EXPERIMENTAL

Pasteurized milk contaminated with killed A(H5) virus

Intervention Type: OTHER

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.

3-Day Group

Participants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits.

Group Type: EXPERIMENTAL

Pasteurized milk contaminated with killed A(H5) virus

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S. Graciaa, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Graciaa, MD, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Hope Clinic

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Graciaa, MD, MPH, MSc

Role: CONTACT

dsgraci@emory.edu

404-712-1370

Facility Contacts

Daniel Graciaa, MD, MPH, MSc

Role: primary

dsgraci@emory.edu

404-712-1370

Other Identifiers

75N93021C00017-P00012-9999-5

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009067

Identifier Type: -

Identifier Source: org_study_id