NCT01913353

A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®

A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN® Smallpox Vaccine to ACAM2000® in 18-42 Year Old Healthy Vaccinia-naïve Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.

Detailed description

To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response at the Peak Visits (Day 42 for Group 1 and Day 28 for Group 2) and by showing that vaccination with MVA-BN® prior to administration of ACAM2000® results in an attenuation of take.

Conditions

• 18-42 Year Old Healthy Vaccinia-naïve Subjects

Interventions

Type	Name	Description
BIOLOGICAL	MVA BN®	0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection
BIOLOGICAL	ACAM2000®	0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle.

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-03-01
• Completion: 2017-08-01
• First posted: 2013-08-01
• Last updated: 2019-12-05
• Results posted: 2019-12-05

Locations

1 site across 1 country: South Korea