WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymphoid Tissues.

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07386509
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Fluad® and Afluria® vaccination — DRUG
    All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles

Study Details

Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.

Key Dates

Start date
Mar 17, 2020
Status verified
Jan 2026
Primary completion
Nov 4, 2022
Completion
Nov 4, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single dose of both Fluad® and Afluria®
    All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly

Primary Outcome Measure

Comparison of antibody titers at Day 28 versus baseline [ Time Frame: Baseline and Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine Infectious Disease Clinical Trials Unit.St LouisMissouri63110-

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Washington University School of Medicine Infectious Disease Clinical Trials Unit.· St Louis, MO

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