Trial reportPloS one2011
Partially randomized, non-blinded trial of DNA and MVA therapeutic vaccines based on hepatitis B virus surface protein for chronic HBV infection.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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.
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.
Who cites it
33 citing papers in PubMed, 68 citations in OpenAlex.
- MVA E2 therapeutic vaccine for marked reduction in likelihood of recurrence of respiratory papillomatosis.Head & neck · 2019Trial
- Regression of human papillomavirus intraepithelial lesions is induced by MVA E2 therapeutic vaccine.Human gene therapy · 2014Trial
- Functional Cure for Hepatitis B Virus: Challenges and Achievements.International journal of molecular sciences · 2025Review
- Under-representation of the WHO African region in clinical trials of interventions against hepatitis B virus infection.The lancet. Gastroenterology & hepatology · 2024Review
- Article
- Title: Immunotherapy; a ground-breaking remedy for spinal cord injury with stumbling blocks: An overview.Frontiers in pharmacology · 2023Review
- Hepatitis B Therapeutic Vaccine: A Patent Review.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Extracellular Vesicles and Their Use as Vehicles of Immunogens.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Therapeutic vaccination for treatment of chronic hepatitis B.Clinical and experimental immunology · 2021Review
- Designing the next-generation therapeutic vaccines to cure chronic hepatitis B: focus on antigen presentation, vaccine properties and effect measures.Clinical & translational immunology · 2021Review
- Viral Related Tools against SARS-CoV-2.Viruses · 2020Review
- New Approaches to the Treatment of Chronic Hepatitis B.Journal of clinical medicine · 2020Review
- CD69 Targeting Enhances Anti-vaccinia Virus Immunity.Journal of virology · 2019Article
- Primary Human B Cells at Different Differentiation and Maturation Stages Exhibit Distinct Susceptibilities to Vaccinia Virus Binding and Infection.Journal of virology · 2019Article
- HBV Immune-Therapy: From Molecular Mechanisms to Clinical Applications.International journal of molecular sciences · 2019Review
- Hazard Characterization of Modified Vaccinia Virus Ankara Vector: What Are the Knowledge Gaps?Viruses · 2017Review
- Drugs in Development for Hepatitis B.Drugs · 2017Review
- In Silico Analysis of Epitope-Based Vaccine Candidates against Hepatitis B Virus Polymerase Protein.Viruses · 2017Article
- Current progress in the development of therapeutic vaccines for chronic hepatitis B virus infection.Iranian journal of basic medical sciences · 2016Review
- The evolution of poxvirus vaccines.Viruses · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 6 countries.
Funding
Abstract
backgroundChronic HBV infects 350 million people causing cancer and liver failure. We aimed to assess the safety and efficacy of plasmid DNA (pSG2.HBs) vaccine, followed by recombinant modified vaccinia virus Ankara (MVA.HBs), encoding the surface antigen of HBV as therapy for chronic HBV. A secondary goal was to characterize the immune responses.
methodsFirstly 32 HBV e antigen negative (eAg(-)) participants were randomly assigned to one of four groups: to receive vaccines alone, lamivudine (3TC) alone, both, or neither. Later 16 eAg(+) volunteers in two groups received either 3TC alone or both 3TC and vaccines. Finally, 12 eAg(-) and 12 eAg(+) subjects were enrolled into higher-dose treatment groups. Healthy but chronically HBV-infected males between the ages of 15-25 who lived in the western part of The Gambia were eligible. Participants in some groups received 1 mg or 2 mg of pSG2.HBs intramuscularly twice followed by 5×10(7) pfu or 1.5×10(8) pfu of MVA.HBs intradermally at 3-weekly intervals with or without concomitant 3TC for 11-14 weeks. Intradermal rabies vaccine was administered to a negative control group. Safety was assessed clinically and biochemically. The primary measure of efficacy was a quantitative PCR assay of plasma HBV. Immunity was assessed by IFN-γ ELISpot and intracellular cytokine staining.
resultsMild local and systemic adverse events were observed following the vaccines. A small shiny scar was observed in some cases after MVA.HBs. There were no significant changes in AST or ALT. HBeAg was lost in one participant in the higher-dose group. As expected, the 3TC therapy reduced viraemia levels during therapy, but the prime-boost vaccine regimen did not reduce the viraemia. The immune responses were variable. The majority of IFN-γ was made by antigen non-specific CD16(+) cells (both CD3(+) and CD3(-)).
conclusionsThe vaccines were well tolerated but did not control HBV infection.
trial registrationISRCTN ISRCTN67270384.
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What OpenQuestion holds
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.