Systems Biological Assessment of the Durability of Vaccine Responses

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Emory Winship Cancer Institute
RECRUITING
Atlanta
The Hope Clinic of Emory University
RECRUITING
Decatur
Contact Information
Primary
Nadine Rouphael, MD
nroupha@emory.edu
404-712-1435
Time Frame
Start Date: 2023-04-11
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 66
Treatments
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.
Sponsors
Collaborators: Open Philanthropy, Defense Advanced Research Projects Agency
Leads: Emory University

This content was sourced from clinicaltrials.gov