Evidence map›Paper›PMID 24394187›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2014

Immunological and antiviral responses after therapeutic DNA immunization in chronic hepatitis B patients efficiently treated by analogues.

O Godon, H Fontaine, S Kahi, J F Meritet, D Scott-Algara, S Pol, M L Michel, M Bourgine, ANRS HB02 study group

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02505009 (Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT02505009 phase4completednot on this mapstarted 2015, after this paper: background citation

Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy: a Pilot Study

TypeinterventionalSponsorChang Gung Memorial HospitalRan2015 to 2018Enrolled116ConditionsChronic Hepatitis BArmsEngerix-B, Tenofovir, Entecavir
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. HBVZ10, an AAV8 vector-based new HBV therapy candidate for cccDNA elimination.Molecular therapy. Methods & clinical development · 2025
    Article
  6. Article
  7. Review
  8. Immune therapies against chronic hepatitis B.Journal of gastroenterology · 2022
    Review
  9. Review
  10. Article
  11. Review
  12. [Clinical cure strategy for hepatitis B: immunomodulatory therapy].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2020
    Article
  13. Article
  14. Article
  15. Review
  16. HBV Immune-Therapy: From Molecular Mechanisms to Clinical Applications.International journal of molecular sciences · 2019
    Review
  17. Heterogeneity of HBV-Specific CD8Frontiers in immunology · 2019
    Review
  18. Review
  19. Review
  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 3 institutions in 1 country.

O GodonDépartment de Virologie, Institut Pasteur, Laboratoire de pathogénèse des virus de l'hépatite B and INSERM U845, Paris, France.
H FontaineInstitut Cochin, CNRS (UMR 8104) and INSERM U-1016, Université Paris Descartes, et Assistance Publique-Hôpitaux de Paris, Service d'Hépatologie, Cochin Hospital, Paris, France.
S KahiINSERM SC10, Villejuif, France.
J F MeritetVirology Unit, Cochin Hospital, Paris, France.
D Scott-AlgaraDépartment de Virologie, Institut Pasteur, Unité des Régulations des Infections rétrovirales, Paris, France.
S PolInstitut Cochin, CNRS (UMR 8104) and INSERM U-1016, Université Paris Descartes, et Assistance Publique-Hôpitaux de Paris, Service d'Hépatologie, Cochin Hospital, Paris, France.
M L MichelDépartment de Virologie, Institut Pasteur, Laboratoire de pathogénèse des virus de l'hépatite B and INSERM U845, Paris, France.
M BourgineDépartment de Virologie, Institut Pasteur, Laboratoire de pathogénèse des virus de l'hépatite B and INSERM U845, Paris, France. Electronic address: maryline.bourgine@pasteur.fr.
ANRS HB02 study group
Institut Pasteur · FRHôpital Cochin · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A substudy of a phase I/II, prospective, multicenter clinical trial was carried out to investigate the potential benefit of therapeutic vaccination on hepatitis B e antigen-negative patients with chronic hepatitis B (CHB), treated efficiently with analogues. Patients were randomized in 2 arms, one receiving a hepatitis B virus (HBV) envelope DNA vaccine, and one without vaccination. At baseline, HBV-specific interferon (IFN)-γ-producing T cells were detected in both groups after in vitro expansion of peripheral blood mononuclear cells. Vaccine-specific responses remained stable in the vaccine group, whereas in the control group the percentage of patients with HBV-specific IFN-γ-producing T cells decreased over time. The vaccine-specific cytokine-producing T cells were mostly polyfunctional CD4(+) T cells, and the proportion of triple cytokine-producer T cells was boosted after DNA injections. However, these T-cell responses did not impact on HBV reactivation after stopping analogue treatment. Importantly, before cessation of treatment serum hepatitis B surface antigen (HBsAg) titers were significantly associated with DNA or HBsAg clearance. Therapeutic vaccination in CHB patients with persistent suppression of HBV replication led to the persistence of T-cell responses, but further improvements should be searched for to control infection after treatment discontinuation.

Indexed as

AdultAgedCombined Modality TherapyDNA, ViralFemaleHepatitis B, ChronicHepatitis B e AntigensHepatitis B VaccinesHepatitis B virusHumansInterferon-gammaMaleMiddle AgedProspective StudiesT-LymphocytesVaccines, DNADNA, ViralHepatitis B e AntigensHepatitis B VaccinesInterferon-gammaVaccines, DNAViral Envelope Proteins

Identifiers

PMID24394187
PMCPMC3944344
OpenAlexW2084190034

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.