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NCT04142086: VYF01
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
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.
24 June 2021
Quick facts
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 73 |
| Start date | 15 January 2020 |
| Primary completion | 24 June 2021 |
| Estimated completion | 24 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine — full drug profile →
- Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine — full drug profile →
- Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine — full drug profile →
- Yellow fever vaccine — full drug profile →
Conditions studied
- Yellow Fever (Healthy Volunteers) — all drugs for Yellow Fever (Healthy Volunteers) →
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):
-
The Present and Future of Yellow Fever Vaccines.
Hansen CA, Barrett ADT. · · 2021 · cited 49× · PMID 34577591 · DOI 10.3390/ph14090891 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04142086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04142086 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04142086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing