Actively Recruiting
Durability of Vaccine Responses
Led by Emory University · Updated on 2025-07-01
66
Participants Needed
3
Research Sites
181 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
D
Defense Advanced Research Projects Agency
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Durability of Vaccine Responses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and give informed consent.
- Age 18-50 years.
- Agree not to take any live vaccines 30 days before or after vaccination.
- Agree not to take any inactivated vaccines 14 days before or after vaccination.
- Women of childbearing potential must agree to use effective birth control for the first 3 months of the study.
- Negative urine pregnancy test documented prior to vaccination and tissue sampling procedures for women who can become pregnant.
You will not qualify if you...
- History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products.
- History of medical conditions causing impaired immunity, such as HIV infection, cancer (especially leukemia or lymphoma), use of immunosuppressive or antineoplastic drugs, or X-ray treatment.
- History of Hepatitis B or C infection.
- Chronic serious medical problems affecting immune response or requiring immune-affecting medication, including insulin-dependent diabetes, severe heart, lung, liver, or kidney disease, and grade 4 hypertension.
- Thymus gland problems or removal or uncontrolled autoimmune disorder.
- Pregnancy, breastfeeding, or plans to become pregnant in the first 3 months.
- Receipt of blood products or immune globulin within the prior 3 months.
- Active duty military personnel.
- History of excessive alcohol use, drug use, psychiatric, social, or occupational conditions that may prevent study compliance.
- For yellow fever vaccine group: history of yellow fever, West Nile, Dengue, St. Louis encephalitis, or Japanese encephalitis vaccination or infection; previous residence in a country at risk for yellow fever virus; allergy to eggs, chicken, or gelatin.
- For influenza vaccine group: history of influenza infection within the same influenza season.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
The Hope Clinic of Emory University
Decatur, Georgia, United States, 30030
Actively Recruiting
Research Team
N
Nadine Rouphael, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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