H5N1 Milk Detection Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06850298
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 9, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1-Day Group
    Participants will consume 250 mL of pasteurized commercial milk at a study visit.
  • Experimental: 3-Day Group
    Participants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits.

Primary Outcome Measure

Proportion of respiratory specimens with influenza detected [ Time Frame: Up to 30 days after milk consumption ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hope ClinicAtlantaGeorgia30322
Daniel Graciaa, MD, MPH, MSc
[email protected]
404-712-1370
Daniel Graciaa, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hope Clinic· Atlanta, GA

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