NCT06899802

A Phase 2 Trial in Healthy Adult Participants of the Recombinant MVA-BN-WEV Vaccine

A Two-stage, Randomized, Double-blind, Dose Ranging Phase 2 Trial in Healthy Adult Participants to Investigate Optimal Dose and Dosing Regimen, and to Evaluate Safety and Immunogenicity of the Recombinant MVA-BN-WEV Vaccine

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This phase 2 clinical trial will investigate an optimal dose, dosing regimen, and evaluate reactogenicity, safety and immunogenicity in healthy adult participants of the recombinant, multivalent MVA-BN-WEV vaccine. MVA-BN-WEV is intended for active immunization for prevention of disease induced by VEEV and EEEV, in persons aged 18 years and older at high risk of exposure.

Conditions

• Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-WEV	MVA-mBN396 (common name MVA-BN-WEV vaccine), is a highly attenuated, live recombinant virus based on the licensed viral vector MVA-BN, provided as a liquid frozen formulation. It is administered as an intramuscular injection.
OTHER	Placebo	Tris-Buffered Saline (TBS) (placebo) is a clear liquid, free from visible extraneous particles. TBS is acceptable for use as a diluent and for intramuscular injection.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2025-03-28
• Last updated: 2025-10-01

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study