NCT01913353 is a Phase 3 clinical trial of MVA BN® in 18-42 Year Old Healthy Vaccinia-naïve Subjects, sponsored by Bavarian Nordic.

Who is sponsoring NCT01913353?

NCT01913353 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT01913353?

Interventions in NCT01913353: MVA BN®, ACAM2000®.

What condition does NCT01913353 study?

NCT01913353 studies 18-42 Year Old Healthy Vaccinia-naïve Subjects.

Is NCT01913353 still recruiting?

NCT01913353 is currently completed. Last updated 18 November 2019.

Are results published for NCT01913353?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-18 · How we verify

NCT01913353

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 18 November 2019

What this trial tests

Phase 3 trial testing MVA BN® in 18-42 Year Old Healthy Vaccinia-naïve Subjects in 440 participants. Completed in 1 August 2017.

Timeline

1 March 2015

Primary endpoint
1 March 2017

1 August 2017

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	440
Start date	1 March 2015
Primary completion	1 March 2017
Estimated completion	1 August 2017
Sites	1 location across South Korea

Drugs / interventions tested

MVA BN® — full drug profile →
ACAM2000®

Conditions studied

18-42 Year Old Healthy Vaccinia-naïve Subjects — all drugs for 18-42 Year Old Healthy Vaccinia-naïve Subjects →

Sponsor

Bavarian Nordic — full company profile →

Who can join

Adults 18 to 42, any sex, with 18-42 Year Old Healthy Vaccinia-naïve Subjects. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits
Time frame: Day 42 for Group 1 and Day 28 for Group 2
GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of 1.
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 1st vaccination for Group 2
The MLA was defined as the maximum of two measurements: the lesion area measured on Day 6-8 (after scarification) or the lesion area measured on Day 13-15 (after scarification). This was measured using the SilhouetteConnect camera system, and confirmed by the Independent Take Review Committee (ITRC).

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox.
Pittman PR, Hahn M, Lee HS, Koca C, et al · · 2019 · cited 190× · PMID 31722150 · DOI 10.1056/nejmoa1817307
Monkeypox: epidemiology, pathogenesis, treatment and prevention.
Huang Y, Mu L, Wang W. · · 2022 · cited 166× · PMID 36319633 · DOI 10.1038/s41392-022-01215-4
Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases.
Wang S, Liang B, Wang W, Li L, et al · · 2023 · cited 124× · PMID 37029123 · DOI 10.1038/s41392-023-01408-5
Current Advances in Zika Vaccine Development.
Wang Y, Ling L, Zhang Z, Marin-Lopez A. · · 2022 · cited 60× · PMID 36366325 · DOI 10.3390/vaccines10111816
Monkeypox Virus: Epidemiology, Virology, Diagnosis, Vaccine, and Therapeutics.
Yan Y, Sun Y, Sun G, Niu C, et al · · 2026 · cited 2× · PMID 41488472 · DOI 10.1002/mco2.70525

Verify or expand the search:

Other Bavarian Nordic trials

Trials by the same sponsor.

NCT07199569 — Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells · Phase 2 · active not recruiting
NCT06549530 — Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years · Phase 2 · active not recruiting
NCT05329220 — ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 · Phase 3 · completed
NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
NCT05238025 — MVA-BN-RSV Vaccine Trial · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01913353 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
Last refreshed: 18 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01913353.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing