Recruiting

Inactive Flu Virus

Sponsor:

Emory University

Code:

NCT06850298

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Pasteurized milk contaminated with killed A(H5) virus

Study Details

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

Study ID

NCT06850298

Start date

May 9, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Daniel Graciaa, MD, MPH, MSc

404-712-1370dsgraci@emory.edu

Locations

Hope Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Daniel Graciaa, MD, MPH, MSc

404-712-1370dsgraci@emory.edu

Principal Investigator:

Daniel Graciaa, MD

More Information

Sponsor

Emory University

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-15.