Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA (NCT04942210)
🩺 Plain-English Summary (8th-Grade Level)
The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants. The secondary objectives of the study are: * To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration. * To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX. * To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (18 items).
Location: Emory University Decatur- Site Number : 8400005 — Decatur, Georgia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known history of flavivirus infection.
- Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- Known history or laboratory evidence of human immunodeficiency virus infection.
- Known history of hepatitis B or hepatitis C seropositivity
- Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia).
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion, including malignancy, such as leukemia, or lymphoma.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Administration of any anti-viral within 2 months preceding the vaccination and up to the 6 weeks following the vaccination
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against a flavivirus disease at any time including YF with either the study vaccine or another vaccine.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- Emory University Decatur- Site Number : 8400005 — Decatur, Georgia
- Velocity Clinical Research- New Orleans Site Number : 8400008 — New Orleans, Louisiana
- Johns Hopkins Bloomberg School of Public Health (JHSPH)- Site Number : 8400004 — Baltimore, Maryland
- Harvard University Medical School- Site Number : 8400002 — Boston, Massachusetts
- Saint Louis University- Site Number : 8400003 — St Louis, Missouri
- Meridian Clinical Research- Site Number : 8400009 — Omaha, Nebraska
- SUNY Upstate Medical University Global Health Institute Site Number : 8400006 — East Syracuse, New York
- New York University Langone Medical Center Site Number : 8400013 — New York, New York
- Rochester Clinical Research, Inc.- Site Number : 8400010 — Rochester, New York
- Velocity Clinical Research - Providence Site Number : 8400015 — East Greenwich, Rhode Island
- J Lewis Research Inc- Site Number : 8400012 — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.