Actively Recruiting
Systems Biological Assessment of the Durability of Vaccine Responses
Led by Emory University · Updated on 2025-07-01
66
Participants Needed
3
Research Sites
N/A
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
Researchers are investigating why some vaccines provide long-lasting protection while others do not. The yellow fever vaccine (YF-17D) is known for its durable immunity after one dose, whereas the quadrivalent influenza vaccine (QIV) offers shorter protection. This study aims to better understand the immune responses that contribute to lasting protection by comparing these two vaccines in adult volunteers. Participants will receive either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine. After vaccination, biologic samples will be collected from blood, lymph nodes, and bone marrow at various times to study immune system reactions. The study includes a screening visit, vaccination visit, tissue sampling visits with fine needle lymph node aspirates and bone marrow aspirations, and multiple follow-up visits. During the study, participants will provide medical history and medication information, undergo urine pregnancy tests if applicable, and have vital signs recorded. Blood, lymph node, and bone marrow samples will be tested to measure antibody responses up to 270 days after vaccination. Safety monitoring includes tracking adverse events and serious adverse events up to 270 days. The results will help improve understanding of durable vaccine protection and guide future vaccine development.
CONDITIONS
Brief Title
Durability of Vaccine Responses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and give informed consent.
- Age 18 to 50 years.
- Agree not to take any live vaccines 30 days before or after vaccination (14 days for inactivated vaccines).
- Women of childbearing potential must use effective birth control for the first 3 months and have a negative urine pregnancy test prior to vaccination and tissue sampling.
You will not qualify if you...
- History of allergy or serious adverse reaction to a vaccine or vaccine products, including Guillain-Barré syndrome.
- History of medical conditions causing impaired immunity, such as HIV infection, cancer (leukemia, lymphoma), or use of immunosuppressive drugs.
- History of Hepatitis B or C infection.
- Chronic significant medical problems affecting immune response, including insulin-dependent diabetes, severe heart, lung, liver, or kidney disease, or Grade 4 hypertension.
- Thymus gland disorders or uncontrolled autoimmune diseases.
- Pregnancy, breastfeeding, or plans to become pregnant within first 3 months.
- Receipt of blood products or immune globulin within prior 3 months.
- Active duty military status.
- History of excessive alcohol use, drug use, psychiatric, social, or occupational conditions affecting trial compliance.
- For YF-17D arm: prior yellow fever or related vaccinations/infections, residence in yellow fever risk countries, allergy to eggs, chicken, or gelatin.
- For QIV arm: influenza infection during the current influenza season.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either the Yellow Fever Vaccine (YF-17D) or the Quadrivalent seasonal influenza vaccine (QIV). They are observed for at least 20 minutes after vaccination to monitor for any immediate reactions.
1 vaccination visit (in-person)
Duration - Up to several months following vaccination
Participants undergo tissue sampling visits where blood, lymph node, and bone marrow samples are collected to evaluate immune system responses to the vaccine. Lymph node sampling may be done up to two times and bone marrow aspirations up to three times per participant.
Multiple visits depending on sample collection schedule, up to 5 visits
Duration - Up to 9 months after vaccination
Participants attend follow-up visits for monitoring adverse events and immune response over time, up to 270 days after vaccination.
Multiple follow-up visits over 270 days
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
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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