Evidence map›Paper›PMID 29912453›Full record

Trial reportThe Journal of infectious diseases2018

Induction of Cross-Clade Antibody and T-Cell Responses by a Modified Vaccinia Virus Ankara-Based Influenza A(H5N1) Vaccine in a Randomized Phase 1/2a Clinical Trial.

Rory D de Vries, Arwen F Altenburg, Nella J Nieuwkoop, Erwin de Bruin, Stella E van Trierum, Mark R Pronk, Mart M Lamers, Mathilde Richard, David F Nieuwenhuijse, Marion P G Koopmans and 5 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  19. Influenza Vaccines: Successes and Continuing Challenges.The Journal of infectious diseases · 2021
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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

15 authors.

Rory D de VriesDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Arwen F AltenburgDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Nella J NieuwkoopDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Erwin de BruinDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Stella E van TrierumDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Mark R PronkDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Mart M LamersDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Mathilde RichardDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
David F NieuwenhuijseDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Marion P G KoopmansDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Joost H C M KreijtzDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Ron A M FouchierDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Albert D M E OsterhausDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
Gerd SutterInstitute for Infectious Diseases and Zoonoses, Ludwig Maximilian University of Munich, Munich.
Guus F RimmelzwaanDepartment of Viroscience, Postgraduate School of Molecular Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.

Funding

European Research Council 250136NIAID NIH HHS HHSN272201400008C
6 · The paper itself

Abstract

Background: High-pathogenicity avian influenza viruses continue to circulate in poultry and wild birds and occasionally infect humans, sometimes with fatal outcomes. Development of vaccines is a priority to prepare for potential pandemics but is complicated by antigenic variation of the surface glycoprotein hemagglutinin. We report the immunological profile induced by human immunization with modified vaccinia virus Ankara (MVA) expressing the hemagglutinin gene of influenza A(H5N1) virus A/Vietnam/1194/04 (rMVA-H5). Methods: In a double-blinded phase 1/2a clinical trial, 79 individuals received 1 or 2 injections of rMVA-H5 or vector control. Twenty-seven study subjects received a booster immunization after 1 year. The breadth, magnitude, and properties of vaccine-induced antibody and T-cell responses were characterized. Results: rMVA-H5 induced broadly reactive antibody responses, demonstrated by protein microarray, hemagglutination inhibition, virus neutralization, and antibody-dependent cellular cytotoxicity assays. Antibodies cross-reacted with antigenically distinct H5 viruses, including the recently emerged subtypes H5N6 and H5N8 and the currently circulating subtype H5N1. In addition, the induction of T cells specific for H5 viruses of 2 different clades was demonstrated. Conclusions: rMVA-H5 induced immune responses that cross-reacted with H5 viruses of various clades. These findings validate rMVA-H5 as vaccine candidate against antigenically distinct H5 viruses. Clinical Trials Registration: NTR3401.

Indexed as

AdultAntibodies, ViralAntibody-Dependent Cell CytotoxicityCross ReactionsDouble-Blind MethodDrug CarriersFemaleHemagglutination Inhibition TestsHemagglutinin Glycoproteins, Influenza VirusHumansImmunization ScheduleInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleNeutralization TestsAntibodies, ViralDrug Carriershemagglutinin, avian influenza A virusHemagglutinin Glycoproteins, Influenza VirusInfluenza VaccinesVaccines, Synthetic

Identifiers

PMID29912453
PMCPMC6047453

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.