Evidence map›Paper›PMID 23349878›Full record

SynthesisPloS one2013

Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review.

Marnie L Elizaga, Sandhya Vasan, Mary A Marovich, Alicia H Sato, Dale N Lawrence, Bernard R Chaitman, Sharon E Frey, Michael C Keefer, MVA Cardiac Safety Working Group

5 registry-linked trialsOpen access · goldAbstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT00082446 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of MVA-BN in a Dose Response Regimen Followed by Administration of Dryvax in Healthy Adult Volunteers

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2007Enrolled91ConditionsSmallpoxArmsLive vaccinia virus vaccine, MVA Smallpox Vaccine, Placebo
NCT00083603 phase1completednot on this map

A Phase I Trial to Evaluate the Safety and Immunogenicity of rMVA-HIV (rMVA-HIV Env/Gag + rMVA-HIV Tat/Rev/Nef-RT) and rFPV-HIV (rFPV-HIV Env/Gag + rFPV-HIV Tat/Rev/Nef-RT) Vaccines, Alone or in Combination, in Healthy, Vaccinia Naive HIV-1 Negative Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2007Enrolled150ConditionsHIV InfectionsArmsrMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT), rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT), Empty TBC-FPV, TBC-MVA and TBC-FPV
NCT00252148 phase1completednot on this map

Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of a Modified Vaccinia Ankara (MVA) Vectored HIV-1 (ADMVA) Vaccine Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2005 to 2007Enrolled48ConditionsHIV InfectionArmsADMVA
NCT00301184 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA Vaccine and Recombinant Modified Vaccinia Ankara/HIV62 Vaccine in Healthy, HIV-1-Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2008Enrolled120ConditionsHIV InfectionsArmspGA2/JS7 DNA, Modified vaccinia Ankara/HIV62
NCT00428337 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2008Enrolled36ConditionsHIV InfectionsArmsEP-1233, MVA-mBN32
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 31 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  8. Prevention of monkeypox with vaccines: a rapid review.The Lancet. Infectious diseases · 2022
    Review
  9. Monkeypox: epidemiology, pathogenesis, treatment and prevention.Signal transduction and targeted therapy · 2022
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Observational
  18. Article
  19. Observational
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Marnie L ElizagaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Sandhya Vasan
Mary A Marovich
Alicia H Sato
Dale N Lawrence
Bernard R Chaitman
Sharon E Frey
Michael C Keefer
MVA Cardiac Safety Working Group
Fred Hutch Cancer Center · USSaint Louis University · USUniversity of Rochester · USAaron Diamond AIDS Research Center · USNational Institute of Allergy and Infectious Diseases · USWalter Reed Army Institute of Research · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
HIV VACCINE TRIALS NETWORK LEADERSHIP GROUPU01AI046747 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 1999 to 2005
$124.7M
University of Rochester HIV/AIDS Clinical Trials Unit Administrative SupplementUM1AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI Paul R Bohjanen, MICHAEL C KEEFER · 2012 to 2026
$25.7M
Vaccine and Treatment Evaluation UnitN01AI25464 · NIAID · SAINT LOUIS UNIVERSITY · 2007 to 2008
$1.8M
EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025464N01AI025464 · NIAID · SAINT LOUIS UNIVERSITY · PI CHAPLESKI, ELIZABETH · 2003 to 2006
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NIAID NIH HHS N01 AI025464NIAID NIH HHS N01 AI25464NIAID NIH HHS U01 AI046747NIAID NIH HHS UM1 AI046747NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069511PHS HHS UM1 AIO68614
6 · The paper itself

Abstract

backgroundVaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.

methodsFour clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.

resultsFour hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.

conclusionsProspective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.

trial registrationClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.

Indexed as

Clinical Trials, Phase I as TopicSmallpox VaccineEpidemiological MonitoringHeart FailureHumansProspective StudiesSmallpoxUnited StatesUnited States Food and Drug AdministrationVaccinationVaccines, AttenuatedVacciniaVaccinia virusSmallpox VaccineVaccines, Attenuated

Identifiers

PMID23349878
PMCPMC3547923
OpenAlexW2129455109

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.