Influenza
Conditions
Brief summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.
Detailed 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: 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.
Interventions
Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 20-75-year-old male and female patients 2. Body mass index (BMI) 20-35 kg/m2 3. Acceptable laboratory values: Absolute neutrophil count (ANC) \> 750 cells/mm3; Hemoglobin \>10 g/dL; Platelet count \>75,000/mm3; Partial thromboplastin time (PTT) \>1.2x ULN; Prothrombin time (PT) \>1.2x ULN 4. Willing and able to complete the informed consent process 5. Availability for follow-up for the planned duration of the study 6. Acceptable medical history by review of inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAI titer | Day 7 after vaccination | This measures response to influenza vaccine |
Countries
United States
Outcome results
None listed