Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood

NCT03898973 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 50328
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• HAI titer

  This measures response to influenza vaccine

  Day 7 after vaccination

Study Arms (1)

Study Phase

OTHER

Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV)

Biological: Quadrivalent inactivated influenza vaccine (IIV)

Interventions

Quadrivalent inactivated influenza vaccine (IIV) BIOLOGICAL

Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.

Also known as: Fluzone Quadrivalent

Study Phase

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
• Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
• Receipt of blood or blood products within the past 6 months or planned used during the study.
• A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
• Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (\~ 28 days after study vaccination)

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University Medical Center, Lane building L134

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: April 11, 2019
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: November 21, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)