Evidence map›Paper›PMID 23752314›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2013

Therapeutic DNA vaccination using in vivo electroporation followed by standard of care therapy in patients with genotype 1 chronic hepatitis C.

Ola Weiland, Gustaf Ahlén, Helmut Diepolder, Maria-Christina Jung, Sepideh Levander, Michael Fons, Iacob Mathiesen, Niranjan Y Sardesai, Anders Vahlne, Lars Frelin and 1 more

Abstract readClinical TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
–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

41 citing papers in PubMed.

  1. Review
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  12. Promises of Nanotherapeutics in Obesity.Trends in endocrinology and metabolism: TEM · 2019
    Review
  13. Review
  14. Article
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  16. Review
  17. Article
  18. Hepatitis C Virus Infection and Vaccine Development.Journal of clinical and experimental hepatology · 2018
    Review
  19. Article
  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

11 authors.

Ola WeilandDivision of Infectious Diseases, Department of Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden.
Gustaf Ahlén
Helmut Diepolder
Maria-Christina Jung
Sepideh Levander
Michael Fons
Iacob Mathiesen
Niranjan Y Sardesai
Anders Vahlne
Lars Frelin
Matti Sällberg

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clearance of infections caused by the hepatitis C virus (HCV) correlates with HCV-specific T cell function. We therefore evaluated therapeutic vaccination in 12 patients with chronic HCV infection. Eight patients also underwent a subsequent standard-of-care (SOC) therapy with pegylated interferon (IFN) and ribavirin. The phase I/IIa clinical trial was performed in treatment naive HCV genotype 1 patients, receiving four monthly vaccinations in the deltoid muscles with 167, 500, or 1,500 μg codon-optimized HCV nonstructural (NS) 3/4A-expressing DNA vaccine delivered by in vivo electroporation (EP). Enrollment was done with 2 weeks interval between patients for safety reasons. Treatment was safe and well tolerated. The vaccinations significantly improved IFN-γ-producing responses to HCV NS3 during the first 6 weeks of therapy. Five patients experienced 2-10 weeks 0.6-2.4 log10 reduction in serum HCV RNA. Six out of eight patients starting SOC therapy within 1-30 months after the last vaccine dose were cured. This first-in-man therapeutic HCV DNA vaccine study with the vaccine delivered by in vivo EP shows transient effects in patients with chronic HCV genotype 1 infection. The interesting result noted after SOC therapy suggests that therapeutic vaccination can be explored in a combination with SOC treatment.

Indexed as

AdultAntiviral AgentsCombined Modality TherapyElectroporationFemaleHepacivirusHepatitis C, ChronicHumansInterferon-alphaInterferon LambdaInterferonsInterleukinsLymphocyte ActivationMaleMiddle AgedPolyethylene GlycolsAntiviral AgentsInterferon-alphaInterferon Lambdainterferon-lambda, humanInterferonsInterleukinspeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, ViralVaccines, DNAViral Hepatitis Vaccines

Identifiers

PMID23752314
PMCPMC3776630

What OpenQuestion holds

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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.