Systems Biological Assessment of the Durability of Vaccine Responses
Emory University
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.
Description
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 influenza vaccine 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…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Able to understand and give informed consent. * Age 18-50 years. * Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination. * Women of child bearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to tissue sampling procedures. Exclusion Criteria: * History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products. * History of a medical conditi…
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.
Locations (3)
- Emory University HospitalAtlanta, Georgia
- Emory Winship Cancer InstituteAtlanta, Georgia
- The Hope Clinic of Emory UniversityDecatur, Georgia