Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
NCT ID: NCT04142086
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2020-01-15
2021-06-24
Brief Summary
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* To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
* To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
* To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1
1 injection of vYF vaccine Dosage 1
Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Group 2
1 injection of vYF vaccine Dosage 2
Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Group 3
1 injection of vYF vaccine Dosage 3
Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Group 4
1 injection of YF-VAX
Yellow fever vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Interventions
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Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Yellow fever vaccine
Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read and understand the Informed Consent Form which has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination
* Previous vaccination against a flavivirus disease including YF with either the trial vaccine or another vaccine
* Receipt of immune globulins, blood, or blood-derived products in the past 6 months
* 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 trial 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 of family history of thymic pathology (thymoma, thymectomy, or myasthenia)
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction
* 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
* 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
60 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number 8400001
Silver Spring, Maryland, United States
Countries
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References
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Pagnon A, Carre C, Aguirre M, Chautard E, Gimenez S, Raynal F, Feroldi E, Scott P, Modjarrad K, Vangelisti M, Mantel N. Next generation yellow fever vaccine induces an equivalent immune and transcriptomic profile to the current vaccine: observations from a phase I randomised clinical trial. EBioMedicine. 2024 Oct;108:105332. doi: 10.1016/j.ebiom.2024.105332. Epub 2024 Sep 17.
Related Links
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VYF01 Plain Language Results Summary
Other Identifiers
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U1111-1217-1958
Identifier Type: OTHER
Identifier Source: secondary_id
VYF01
Identifier Type: -
Identifier Source: org_study_id
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