Thinking of joining a study?

Register your interest

NCT06850298 | NOT YET RECRUITING | Influenza


H5N1 Milk Detection Study
Sponsor:

Emory University

Information provided by (Responsible Party):

Daniel S. Graca, MD

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. We also want to see if the body produces antibodies in response to this milk consumption.

Condition or disease

Influenza

Intervention/treatment

Pasteurized milk contaminated with killed A(H5) virus

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

H5N1 Milk Detection Study

Location Details

NCT06850298


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Georgia

Hope Clinic

Atlanta, Georgia, United States, 30322

Loading...