NCT03898973

Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent inactivated influenza vaccine (IIV)	Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.

Timeline

• Start date: 2019-04-11
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2019-04-02
• Last updated: 2023-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study