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

NCT01913353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2019-12-05

Study results available
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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.

Conditions

  • 18-42 Year Old Healthy Vaccinia-naïve Subjects

Interventions

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.

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Phillip R Pittman, MD, MPH · US Army Medical Research Institute of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-03-31
Completion
2017-08-31

Countries

  • South Korea

Study Locations

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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 NCT01913353 on ClinicalTrials.gov