Evidence map›Paper›PMID 23482644›Full record

Trial reportThe Journal of infectious diseases2013

Safety and immunogenicity of modified vaccinia Ankara in hematopoietic stem cell transplant recipients: a randomized, controlled trial.

Stephen R Walsh, Marissa B Wilck, David J Dominguez, Elise Zablowsky, Shringkhala Bajimaya, Lisa S Gagne, Kelly A Verrill, Jane A Kleinjan, Alka Patel, Ying Zhang and 7 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00565929 (MVA-BN), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT00565929 phase1completednot on this map

MVA-BN (IMVAMUNE®) Immunization in Persons Who Have Undergone Prior Hematopoietic Stem Cell Transplant (HSCT): A Phase I, Placebo-Controlled Study of the Safety, Reactogenicity and Immunogenicity of MVA Immunization

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2012Enrolled24ConditionsVariola Major (Smallpox)ArmsPlacebo, MVA-BN
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
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  18. Current Status of Vaccine Development for Monkeypox Virus.Advances in experimental medicine and biology · 2024
    Review
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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

17 authors at 5 institutions in 1 country.

Stephen R WalshDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA. srwalsh@bidmc.harvard.edu
Marissa B Wilck
David J Dominguez
Elise Zablowsky
Shringkhala Bajimaya
Lisa S Gagne
Kelly A Verrill
Jane A Kleinjan
Alka Patel
Ying Zhang
Heather Hill
Aruna Acharyya
David C Fisher
Joseph H Antin
Michael S Seaman
Raphael Dolin
Lindsey R Baden
Beth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USEmmes (United States) · USDana-Farber Cancer Institute · USHarvard University · US

Funding

Treatments for Nipah Virus InfectionU54AI057159 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI KASPER, DENNIS L. · 2003 to 2013
$113.7M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
Research Resource Technical Development ComponentU19AI057330 · NIAID · DANA-FARBER CANCER INSTITUTE · PI REINHERZ, ELLIS L · 2003 to 2009
$19.5M
Dermatotropic cellular immune responses induced by a novel smallpox vaccineK23AI085181 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI WALSH, STEPHEN R · 2010 to 2014
$645k
NCRR NIH HHS UL1 RR025758NIAID NIH HHS K23 AI085181NIAID NIH HHS U19 AI057330NIAID NIH HHS U54 AI057159
6 · The paper itself

Abstract

backgroundModified vaccinia Ankara (MVA-BN, IMVAMUNE) is emerging as a primary immunogen and as a delivery system to treat or prevent a wide range of diseases. Defining the safety and immunogenicity of MVA-BN in key populations is therefore important.

methodsWe performed a dose-escalation study of MVA-BN administered subcutaneously in 2 doses, one on day 0 and another on day 28. Twenty-four hematopoietic stem cell transplant recipients were enrolled sequentially into the study, and vaccine or placebo was administered under a randomized, double-blind allocation. Ten subjects received vaccine containing 10(7) median tissue culture infective doses (TCID50) of MVA-BN, 10 subjects received vaccine containing 10(8) TCID50 of MVA-BN, and 4 subjects received placebo.

resultsMVA-BN was generally well tolerated at both doses. No vaccine-related serious adverse events were identified. Transient local reactogenicity was more frequently seen at the higher dose. Neutralizing antibodies (NAb) to Vaccinia virus (VACV) were elicited by both doses of MVA-BN and were greater for the higher dose. Median peak anti-VACV NAb titers were 1:49 in the lower-dose group and 1:118 in the higher-dose group. T-cell immune responses to VACV were detected by an interferon γ enzyme-linked immunosorbent spot assay and were higher in the higher-dose group.

conclusionsMVA-BN is safe, well tolerated, and immunogenic in HSCT recipients. These data support the use of 10(8) TCID50 of MVA-BN in this population. CLINICAL TRIALS REGISTRATION: NCT00565929.

Indexed as

VaccinationAdultAntibodies, NeutralizingAntibodies, ViralAntigens, ViralCell LineDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHematopoietic Stem Cell TransplantationHumansImmunity, CellularImmunocompromised HostMaleMiddle AgedRecombinant ProteinsAntibodies, NeutralizingAntibodies, ViralAntigens, ViralRecombinant Proteinssmallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordicSmallpox VaccineVaccines, Attenuatedclinical trialdoseimmunogenicitymodified vaccinia ankarasafetystem cell transplant

Identifiers

PMID23482644
PMCPMC3654753
OpenAlexW2140220680

What OpenQuestion holds

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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.