Can a new yellow fever vaccine match the old one?
NCT ID NCT04942210
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests an investigational yellow fever vaccine called vYF against the standard YF-VAX vaccine in healthy adults aged 18 to 60. The goal is to see if vYF produces a similar immune response, measured by antibody levels 28 days after a single dose. Researchers will also compare safety and how the body reacts to the two vaccines. Participants must not have had yellow fever or been vaccinated against it before.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an investigational yellow fever vaccine called vYF, made on serum-free Vero cells
- What this could lead to
- If it works, this could provide a new option for yellow fever vaccination that is safer or easier to produce, helping protect more people against the disease.
- What could go wrong
- This is a Phase 2 trial, so the vaccine is still being tested. It may not produce a strong enough immune response or could cause side effects, and further studies would be needed before it could be approved.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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568 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18 years to 60 years on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile. OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration. * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures. 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. * Receipt of immune globulins, blood, or blood-derived products in the past 6 months. * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first year of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first year is permitted (starting the first day of Year 2, and onwards), assuming it does not exclude participation in this study * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Planned travel in a YF endemic country within 6 months of investigational or control vaccine administration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University Decatur- Site Number : 8400005
Decatur, Georgia, 30030, United States
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Harvard University Medical School- Site Number : 8400002
Boston, Massachusetts, 02115, United States
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J Lewis Research Inc- Site Number : 8400012
Salt Lake City, Utah, 84109, United States
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Johns Hopkins Bloomberg School of Public Health (JHSPH)- Site Number : 8400004
Baltimore, Maryland, 21205, United States
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Meridian Clinical Research- Site Number : 8400009
Omaha, Nebraska, 681134, United States
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New York University Langone Medical Center Site Number : 8400013
New York, New York, 10016, United States
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Rochester Clinical Research, Inc.- Site Number : 8400010
Rochester, New York, 14609, United States
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SUNY Upstate Medical University Global Health Institute Site Number : 8400006
East Syracuse, New York, 13057, United States
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Saint Louis University- Site Number : 8400003
St Louis, Missouri, 63104, United States
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Velocity Clinical Research - Providence Site Number : 8400015
East Greenwich, Rhode Island, 02818, United States
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Velocity Clinical Research- New Orleans Site Number : 8400008
New Orleans, Louisiana, 70119, United States
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