Evidence map›Paper›PMID 26439129›Full record

Trial reportPloS one2015

A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis.

Richard N Greenberg, Maria Yadira Hurley, Yadira Hurley, Dinh V Dinh, Serena Mraz, Javier Gomez Vera, Dorothea von Bredow, Alfred von Krempelhuber, Siegfried Roesch, Garth Virgin and 6 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00316602 (A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN®), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00316602 phase2completednot on this map

A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis

TypeinterventionalSponsorBavarian NordicRan2006 to 2010Enrolled632ConditionsAtopic DermatitisArmsIMVAMUNE
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Predicting vaccine effectiveness for mpox.Nature communications · 2024
    Pooled it
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  10. Article
  11. Review
  12. Vaccination in dermatology 2025: Update considering current recommendations of the German Standing Committee on Vaccination.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Review
  13. Biology of Variola Virus.Advances in experimental medicine and biology · 2024
    Review
  14. Review
  15. Article
  16. Identification ofMicrobiology spectrum · 2023
    Article
  17. Review
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  19. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 3 countries.

Richard N GreenbergUniversity of Kentucky School of Medicine, Lexington, KY, United States of America.
Maria Yadira Hurley
Yadira HurleySaint Louis University, Department of Dermatology, Saint Louis, MO, United States of America.
Dinh V DinhRx Clinical Research, Inc., Garden Grove, CA, United States of America.
Serena MrazVallejo Dermatology Office, Vallejo, CA, United States of America.
Javier Gomez VeraHospital Regional Lic. Adolfo Lopez Mateos, ISSSTE, Mexico City, Mexico.
Dorothea von BredowBavarian Nordic GmbH, Martinsried, Germany.
Alfred von KrempelhuberBavarian Nordic GmbH, Martinsried, Germany.
Siegfried RoeschBavarian Nordic GmbH, Martinsried, Germany.
Garth VirginBavarian Nordic GmbH, Martinsried, Germany.
Nathaly Arndtz-WiedemannBavarian Nordic GmbH, Martinsried, Germany.
Thomas Peter MeyerBavarian Nordic GmbH, Martinsried, Germany.
Darja SchmidtBavarian Nordic GmbH, Martinsried, Germany.
Richard NicholsBavarian Nordic GmbH, Martinsried, Germany.
Philip YoungBavarian Nordic GmbH, Martinsried, Germany.
Paul ChaplinBavarian Nordic GmbH, Martinsried, Germany.
Bavarian Nordic (Germany) · DEInstitute for Social Security and Services for State Workers · MXKaiser Permanente Vallejo Medical Center · USQuest Clinical Research (United States) · USSaint Louis University · USUniversity of Kentucky · US

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR000117 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$13.3M
Production and Testing of a MVA Vaccine-266040072N01AI040072 · NIAID · Bavarian Nordic A/S · 2005 to 2005
–
NCATS NIH HHS UL1 TR000117NIAID NIH HHS N01 AI040072NIAID NIH HHS N01-AI-40072
6 · The paper itself

Abstract

backgroundReplicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD). Prior studies evaluating Modified Vaccinia Ankara virus (MVA), a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers.

objectiveThis Phase II study compared the safety and immunogenicity of MVA enrolling groups of 350 subjects with AD (SCORAD ≤ 30) and 282 healthy subjects.

methodsSubjects were vaccinated twice with MVA, each dose given subcutaneously 4 weeks apart. Adverse events, cardiac parameters, and the development of vaccinia virus humoral immune responses were monitored.

resultsThe overall safety of the vaccine was similar in both groups. Adverse events affecting skin were experienced significantly more often in subjects with AD, but the majority of these events were mild to moderate in intensity. Seroconversion rates and geometric mean titers for total and neutralizing vaccinia-specific antibodies in the AD group were non-inferior compared to the healthy subjects. LIMITATIONS: The size of the study population limited the detection of serious adverse events occurring at a frequency less than 1%.

conclusionMVA has a favorable safety profile and the ability to elicit vaccinia-specific immune responses in subjects with AD.

trial registrationClinicalTrials.gov NCT00316602.

Indexed as

VaccinationAdolescentAdultAntibody FormationDermatitis, AtopicHumansSmallpox VaccineVaccinia virusViral VaccinesYoung AdultSmallpox VaccineViral Vaccines

Identifiers

PMID26439129
PMCPMC4595076
OpenAlexW2129821088

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.