CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
MVA BN® +1 morebiological
Likely dose
MVA BN® 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01913353
NCT01913353Phase 3Completed
CompareCT.gov

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

Bavarian Nordic·interventional·Posted Aug 1, 2013·Updated Dec 5, 2019

In Brief

A Phase 3 clinical trial evaluating MVA BN® and ACAM2000® for 18-42 Year Old Healthy Vaccinia-naïve Subjects. Completed, enrolled 440 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Conditions18-42 Year Old Healthy Vaccinia-naïve Subjects
CountriesSouth Korea
CollaboratorsUS Army Medical Research Institute of Infectious Diseases

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 1, 2013
Enrollment StartMar 1, 2015
Primary CompletionMar 1, 2017
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.9 years ago

Interventions

MVA BN®biological

0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection

ACAM2000®biological

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.