InfluenzaNCT06850298
H5N1 Milk Detection Study
A study testing Pasteurized milk contaminated with killed A(H5) virus in people with Influenza, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Pasteurized milk contaminated with killed A(H5) virus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hope Clinic
Atlanta, Georgia, 30322
Daniel Graciaa, MD, MPH, MSc, 404-712-1370, dsgraci@emory.edu
Daniel Graciaa, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Pasteurized milk contaminated with killed A(H5) virus
- Keywords
- Pasteurized Milk, Flu Virus A (H5), H5N1 avian influenza A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized milk contaminated with killed A(H5) virusOther
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 group | Role | What they receive |
|---|---|---|
| 1-Day Group | Experimental | Participants will consume 250 mL of pasteurized commercial milk at a study visit. Receives: 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. Receives: Other: Pasteurized milk contaminated with killed A(H5) virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days after milk consumption
Secondary outcomes (1)
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.
Measured: Up to 30 days after milk consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start9 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S. Graciaa, MD, Emory University
- Investigators
- Daniel Graciaa, MD, MPH, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850298
- Sponsor's protocol ID
- STUDY00009067
- Other IDs
- 75N93021C00017-P00012-9999-5, 2025P010412
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share deidentified respiratory testing results.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens
- ClinicalTrials.gov ID
- NCT06850298
- Acronym / sponsor ID
- STUDY00009067
- Conditions
- Influenza
- Keywords
- Pasteurized Milk, Flu Virus A (H5), H5N1 avian influenza A
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Day Group | Experimental | Other: Pasteurized milk contaminated with killed A(H5) virusParticipants will consume 250 mL of pasteurized commercial milk at a study visit. |
| 3-Day Group | Experimental | Other: Pasteurized milk contaminated with killed A(H5) virusParticipants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasteurized milk contaminated with killed A(H5) virusMilk 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. | Other | 1-Day Group, 3-Day Group |
Primary outcome
Proportion of respiratory specimens with influenza detected
Time frame: Up to 30 days after milk consumption
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
1 secondary outcome
Severe adverse events after milk consumption
Time frame: Up to 30 days after milk consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. The research team will share deidentified respiratory testing results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Graciaa, MD, MPH, MSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized milk contaminated with killed A(H5) virus in people with Influenza, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Graciaa, MD, MPH, MSc (404-712-1370, dsgraci@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of respiratory specimens with influenza detected (time frame: Up to 30 days after milk consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.