Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood

Stanford University1 site in 1 countryApril 11, 2019

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Stanford University
Locations: 1
Primary Endpoint: HAI titer
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2019

End Date

November 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Philip Grant

Assistant Professor of Medicine (Infectious Diseases)

Stanford University

Eligibility Criteria

Inclusion Criteria

•20-75-year-old male and female patients
•Body mass index (BMI) 20-35 kg/m2
•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
•Willing and able to complete the informed consent process
•Availability for follow-up for the planned duration of the study
•Acceptable medical history by review of inclusion/exclusion criteria

Exclusion Criteria

•Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
•Life-threatening reactions to previous influenza vaccinations
•Allergy to egg or egg products or to vaccine components
•Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
•History of immunodeficiency (including HIV infection)
•Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
•Chronic Hepatitis B or C.
•Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
•Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
•Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.