H5N1 Milk Detection Study

NCT06850298 | Recruiting DMC

• 3 other identifiers: STUDY0000906775N93021C00017-P00012-9999-52025P010412
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Pasteurized Milk; Flu Virus A (H5); H5N1 avian influenza A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severe adverse events after milk consumption

  Up to 30 days after milk consumption

Study Arms (2)

1-Day Group

EXPERIMENTAL

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

Other: Pasteurized milk contaminated with killed A(H5) virus

3-Day Group

EXPERIMENTAL

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

Interventions

Pasteurized milk contaminated with killed A(H5) virus 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.

1-Day Group; 3-Day Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Hope Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Graciaa, MD, MPH, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Graciaa, MD, MPH, MSc

CONTACT

404-712-1370; dsgraci@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Data will be available for access in a public database such as Dataverse.

Locations

US (1)