Actively Recruiting

Phase 4
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT05801978

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

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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