ArticlePloS one2015
Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.
Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00316524 (A Partially Randomized, Partially Double-blind, Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN®), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled 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.
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.
A Partially Randomized, Partially Double-blind, Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Predicting vaccine effectiveness for mpox.Nature communications · 2024Pooled it
- Safety and Efficacy of Post-Eradication Smallpox Vaccine as an Mpox Vaccine: A Systematic Review with Meta-Analysis.International journal of environmental research and public health · 2023Pooled it
- Trial
- Equivalence of freeze-dried and liquid-frozen formulations of MVA-BN as smallpox and mpox vaccine.Human vaccines & immunotherapeutics · 2024Trial
- One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines.The Journal of infectious diseases · 2023Trial
- Trial
- Trial
- A Review of the Past, Present, and Future of the Monkeypox Virus: Challenges, Opportunities, and Lessons from COVID-19 for Global Health Security.Microorganisms · 2023Review
- Review
- Prevention of monkeypox with vaccines: a rapid review.The Lancet. Infectious diseases · 2022Review
- Monkeypox: epidemiology, pathogenesis, treatment and prevention.Signal transduction and targeted therapy · 2022Review
- Development of Modified Vaccinia Virus Ankara-Based Vaccines: Advantages and Applications.Vaccines · 2022Review
- Preventing the Next Pandemic: Is Live Vaccine Efficacious against Monkeypox, or Is There a Need for Killed Virus and mRNA Vaccines?Vaccines · 2022Review
- Review
- NF-κB as an Important Factor in Optimizing Poxvirus-Based Vaccines against Viral Infections.Pathogens (Basel, Switzerland) · 2020Review
- Review
- Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Article
- Article
- Modified Vaccinia Virus Ankara: History, Value in Basic Research, and Current Perspectives for Vaccine Development.Advances in virus research · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundConventional smallpox vaccines based on replicating vaccinia virus (VV) strains (e.g. Lister Elstree, NYCBOH) are associated with a high incidence of myo-/pericarditis, a severe inflammatory cardiac complication. A new smallpox vaccine candidate based on a non-replicating Modified Vaccinia Ankara (MVA) poxvirus has been assessed for cardiac safety in a large placebo-controlled clinical trial.
methodsCardiac safety of one and two doses of MVA compared to placebo was assessed in 745 healthy subjects. Vaccinia-naïve subjects received either one dose of MVA and one dose of placebo, two doses of MVA, or two doses of placebo by subcutaneous injection four weeks apart; vaccinia-experienced subjects received a single dose of MVA. Solicited and unsolicited adverse events (AE) and cardiac safety parameters (recorded as Adverse Events of Special Interest, AESI) were monitored after each injection.
resultsA total of 5 possibly related AESI (3 cases of palpitations, 2 of tachycardia) were reported during the study. No case of myo- or pericarditis occurred. One possibly related serious AE (SAE) was reported during the 6-month follow-up period (sarcoidosis). The most frequently observed AEs were injection site reactions.
conclusionsVaccination with MVA was safe and well tolerated and did not increase the risk for development of myo-/pericarditis.
trial registrationClinicalTrials.gov NCT00316524.
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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.