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

NCT07199569 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2026-04-08

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199569 on ClinicalTrials.gov