Durability of Vaccine Responses

Conditions

• Vaccine Response

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Live Attenuated Yellow Fever 17D Vaccine — BIOLOGICAL
  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.
• Quadrivalent seasonal influenza vaccine — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Apr 11, 2023

Status verified

Jun 2025

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

66 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: YF-17D Vaccination
  Yellow Fever Vaccine (YF-17D) vaccination: Eligible participants will be asked to read the Vaccine Information Sheet for YF-17D per the Centers for Disease Control and Prevention (CDC) guidelines. Participants will then receive the YF-17D vaccine. They will be observed for a minimum of 20 minutes for any immediate hypersensitivity reactions. They will also be given the International Certificate of Vaccination documenting receipt of YF-17D.
• Experimental: QIV Vaccination
  Quadrivalent seasonal influenza vaccine (QIV) vaccination: Eligible participants will be asked to read the Vaccine Information Sheet for QIV per the CDC guidelines. Participants will then receive QIV. They will be observed for a minimum of 20 minutes for any immediate hypersensitivity reactions.

Primary Outcome Measure

Magnitude of neutralizing antibody (nAB) response against YF-17D in blood [ Time Frame: Up to 270 days after vaccination ]

Central Contacts

• Nadine Rouphael, MD
  404-712-1435
  [email protected]

Locations (3)

Find similar trials in Atlanta, GA

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