NCT03699124

Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial

A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN® Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,129 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar. Approximately 1110 subjects will be randomly enrolled into one of three groups: Group 1 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1). Group 2 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2). Group 3 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3). The primary objective of the trial is to show that the immune response elicited (produced) by three consecutively produced MVA-BN lots are statistically (numerically) comparable.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	FD MVA-BN	Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)

Timeline

• Start date: 2019-06-19
• Primary completion: 2020-01-06
• Completion: 2020-06-22
• First posted: 2018-10-09
• Last updated: 2021-05-27
• Results posted: 2021-05-27

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study