Influenza
Conditions
Keywords
Pasteurized Milk, Flu Virus A (H5), H5N1 avian influenza A
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.
Interventions
OTHERPasteurized 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.
Sponsors
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of respiratory specimens with influenza detected | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse events after milk consumption | Up to 30 days after milk consumption | Participants will be asked to call the site if they develop any adverse events for the entire the study participation. |
Countries
United States
Contacts
CONTACTDaniel Graciaa, MD, MPH, MSc
PRINCIPAL_INVESTIGATORDaniel Graciaa, MD, MPH, MSc
Emory University
Outcome results
None listed