Clinical Trial: A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: To demonstrate the efficacy of MVA-BN® by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.
Detailed Summary: 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.
Sponsor: Bavarian Nordic
Current Primary Outcome:
- PRNT GMT at the Peak Visits [ Time Frame: Day 42 for Group 1 and Day 28 for Group 2 ]To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of vaccinia-specific PRNT antibody response at the Peak Visits.
- Maximum Lesion Area (MLA) in mm² after scarification with ACAM2000® [ Time Frame: Day 6-8, 13-15 after 3rd Vaccination for Group 1 and Day 6-8, 13-15 after first vaccination for Group 2 ]To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of showing that vaccination with MVA-BN® prior to scarification with ACAM2000® results in an attenuation of take.
Original Primary Outcome: Comparison of the take in Group 1 versus the take in Group 2 The correct measurement of the lesion area will be confirmed by a blinded Independent Take Review Committee (ITRC). [ Time Frame: Day 6-8 and day 13-15, respectively and healing time up to 2 weeks after scarification with ACAM2000®. ]
Comparison of the take in Group 1 versus the take in Group 2 using a composite endpoint measuring the area of lesion in mm² at day 6-8 and day 13-15, respectively and healing time (i.e. number of days until scab separates from the skin) after scarification with ACAM2000®.
The correct measurement of the lesion area will be confirmed by a blinded Independent Take Review Committee (ITRC).
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bavarian Nordic
Dates:
Date Received: July 26, 2013
Date Started: March 2015
Date Completion: September 2017
Last Updated: November 24, 2016
Last Verified: November 2016