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RECRUITINGINTERVENTIONAL

H5N1 Milk Detection Study

Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Individuals aged 18-64 years - BMI ≤ 35 kg/m2 - Able to understand and give willing to sign a consent form (American English) and comply with study visits and procedures. - In good general health based on medical history and the investigator's clinical judgment. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

Locations (1)

Hope Clinic
Atlanta, Georgia, United States