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NCT04142086: VYF01

Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults

Completed Phase 1 Last updated 22 September 2025
What this trial tests

Phase 1 trial testing Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine in Yellow Fever (Healthy Volunteers) in 73 participants. Completed in 24 June 2021.

Timeline
15 January 2020
Primary endpoint
24 June 2021
24 June 2021

Quick facts

Lead sponsorSanofi Pasteur, a Sanofi Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment73
Start date15 January 2020
Primary completion24 June 2021
Estimated completion24 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 18 to 60, any sex, with Yellow Fever (Healthy Volunteers). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objectives of the study are: * 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Present and Future of Yellow Fever Vaccines.
    Hansen CA, Barrett ADT. · · 2021 · cited 49× · PMID 34577591 · DOI 10.3390/ph14090891
  2. A Yellow Fever Virus 17D Infection and Disease Mouse Model Used to Evaluate a Chimeric Binjari-Yellow Fever Virus Vaccine.
    Yan K, Vet LJ, Tang B, Hobson-Peters J, et al · · 2020 · cited 39× · PMID 32660106 · DOI 10.3390/vaccines8030368
  3. Next generation live-attenuated yellow fever vaccine candidate: Safety and immuno-efficacy in small animal models.
    Piras-Douce F, Raynal F, Raquin A, Girerd-Chambaz Y, et al · · 2021 · cited 18× · PMID 33685778 · DOI 10.1016/j.vaccine.2021.02.033
  4. Next generation yellow fever vaccine induces an equivalent immune and transcriptomic profile to the current vaccine: observations from a phase I randomised clinical trial.
    Pagnon A, Carre C, Aguirre M, Chautard E, et al · · 2024 · PMID 39293214 · DOI 10.1016/j.ebiom.2024.105332

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