NCT07199569

Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells

A Randomized, Double-blind, Phase 2b Comparability Trial in Adults 18 to 49 Years of Age to Assess Immunogenicity, Safety, and Reactogenicity of the MVA-BN Vaccine Manufactured in Different Production Cells

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 970 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Randomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults

Conditions

• Monkeypox (Mpox)

Interventions

Type	Name	Description
BIOLOGICAL	Jynneos	MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).
BIOLOGICAL	MVA-BN (Quail)	MVA-BN manufactured in CCX.E10 quail cell line. Vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U. and is a LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-09-30
• Last updated: 2026-04-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study