RecruitingPhase 4NCT05801978

Durability of Vaccine Responses

Systems Biological Assessment of the Durability of Vaccine Responses

Sponsor

Emory University

Enrollment

66 participants

Start Date

Apr 11, 2023

Study Type

INTERVENTIONAL

Conditions

Vaccine Response

Summary

The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown. This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Live Attenuated Yellow Fever 17D Vaccine and a biological treatment called Quadrivalent seasonal influenza vaccine for people with vaccine response. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLive Attenuated Yellow Fever 17D Vaccine

The FDA-approved YF-17D (YF-VAX®) is a live attenuated vaccine manufactured by Sanofi Pasteur as a one-dose vial. The vaccine is prepared by culturing the 17D-204 strain of yellow fever virus, contains sorbitol and gelatin as a stabilizer, and contains no preservative. Each vial of vaccine is supplied with a separate vial of sterile diluent, which contains sodium chloride injection USP (United States Pharmacopeia) without a preservative.

BIOLOGICALQuadrivalent seasonal influenza vaccine

The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.