Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine

NCT03748524 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 201808171
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.

Conditions

Immunity, Cellular

Keywords

Influenza, B cells, Antibodies, Vaccination

Outcome Measures

Primary Outcomes (1)

• Determine the percentage of subjects achieving seroconversion

  Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28

  0 and day 28

Secondary Outcomes (1)

• Determine the frequency of vaccine-induced responses

  Day7

Study Arms (1)

Single Influenza Vaccine

EXPERIMENTAL

Single Influenza Vaccine,Quadrivalent

Drug: Influenza Vaccine

Interventions

Influenza Vaccine DRUG

Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0

Single Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and give informed consent
• Capable of attending all study visits according to the study schedule.
• Males or females between the ages of 18 to 50 (inclusive).
• Are in good health, as determined by medical history and targeted physical exam related to this history.
• Participants agree not to take any vaccines in the first 60 days after receipt of the influenza vaccine
• The following laboratory values obtained within 14 days prior to entry..
• Absolute neutrophil count (ANC) ≥750 cells/mm3
• Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
• Platelet count ≥100,000/mm3
• Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
• Willing to:
• give FNA specimens for the study. (even if he/she are not willing to give bone marrow aspirates (for any reason), they can be enrolled)
• give bone marrow aspirates, but we cannot locate axillary lymph nodes
• give both FNA and BMA specimens

You may not qualify if:

• \. History influenza vaccination for the last three years.
• \. Coagulopathy (primary or iatrogenic) which would contraindicate FNA
• \. Any history of allergy to eggs, chicken or gelatin or to any previous influenza vaccine
• \. Have an acute illness within 72 hours before vaccination.
• \. A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
• \. History of HIV infection, Hepatitis B or Hepatitis C infection
• \. History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension).
• \. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
• \. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
• \. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
• \. Recipient of a blood products or immune globulin product within 42 days of the vaccination visit.
• \. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
• \. Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
• \. Have planned vaccination with any vaccine during first 60 days of study participation.
• \. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine Infectious Disease Clinical Research Unit

St Louis, Missouri, 63110, 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 Officials

• Ali Ellebedy, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 21, 2018
• Study Start: October 29, 2018
• Primary Completion: September 30, 2021
• Study Completion: June 20, 2022
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)