H5N1 Milk Detection Study
ConditionInfluenza
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorEmory University
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Pasteurized milk contaminated with killed A(H5) virus
Other interventionMilk 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 1-Day GroupExperimental treatment 1 intervention
Group B: 3-Day GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 30 days after milk consumptionSecondary 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.
Time frame
Up to 30 days after milk consumptionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov