Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 20 years and 75 years
- Gender
- Both males and females
Description
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age. Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection. The study has a total of 3 visits. Study Procedures: Screening Visit:...
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age. Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection. The study has a total of 3 visits. Study Procedures: Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT). Visit 1: Vaccination Visit: Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination. Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.
Tracking Information
- NCT #
- NCT03898973
- Collaborators
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- Not Provided
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