Trial reportPloS one2018
Treatment of chronic hepatitis B naïve patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III clinical trial).
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 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
60 citing papers in PubMed, 90 citations in OpenAlex.
- Article
- EPIclip: A Novel Approach for the Production of Decorated Virus-Like Particles Mediated by High-Affinity Protein Binding Partners.Vaccines · 2026Article
- Emerging antiviral drugs and immunotherapy for chronic hepatitis B and associated liver disease.Frontiers in immunology · 2026Review
- Do the therapeutic vaccines hold hope for the treatment of hepatitis B?Hepatology international · 2025Review
- Hepatitis Vaccines: Recent Advances and Challenges.Vaccines · 2025Review
- Chronic Hepatitis B: Current Management and Future Directions.Diseases (Basel, Switzerland) · 2025Review
- Identification of low-molecular compounds that inhibit envelope formation of hepatitis B virus.Scientific reports · 2025Article
- [Research progress on new drugs for the treatment of chronic hepatitis B virus infection].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025Review
- Prevalence and Risk Factors of Significant Hepatic Fibrosis in Omani Patients with HBeAg-negative Chronic Hepatitis B Virus Infection: A Retrospective Study.Oman medical journal · 2024Article
- Canadian Association for the Study of the Liver Single Topic Conference on Hepatitis B Virus: 'Progress toward hepatitis B elimination in Canada'.Canadian liver journal · 2024Article
- Harnessing CD8Clinical and translational medicine · 2024Review
- Dysfunction and regulatory interplay of T and B cells in chronic hepatitis B: immunotherapy and emerging antiviral strategies.Frontiers in cellular and infection microbiology · 2024Review
- The potential effect of HBV vaccination on off-treatment HBsAg reversion after interferon-induced HBsAg clearance.Human vaccines & immunotherapeutics · 2023Article
- HBV Vaccines: Advances and Development.Vaccines · 2023Review
- Development of Therapy Based on the Exploration of Biological Events Underlying the Pathogenetic Mechanisms of Chronic Hepatitis B Infection.Biomedicines · 2023Review
- Review
- HBV Infection and Host Interactions: The Role in Viral Persistence and Oncogenesis.International journal of molecular sciences · 2023Review
- PreS1 Containing HBc VLPs for the Development of a Combined Therapeutic/Prophylactic Hepatitis B Vaccine.Microorganisms · 2023Article
- Current progress in the development of prophylactic and therapeutic vaccines.Science China. Life sciences · 2023Review
- Immune microenvironment changes of liver cirrhosis: emerging role of mesenchymal stromal cells.Frontiers in immunology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextCurrent drugs for chronic hepatitis B therapy have a poor efficacy in terms of post-treatment sustained viral suppression and generate important side effects during and after therapy. Therapeutic vaccination with HBV antigens is an attractive alternative to test.
objectiveEvaluating the efficacy of a therapeutic vaccine candidate (designated NASVAC) containing both hepatitis B surface antigen (HBsAg) and core antigen (HBcAg) versus pegylated interferon (Peg-IFN) in naïve chronic hepatitis B patients. DESIGN, SETTING,
participantsAn open phase III, randomised and treatment controlled clinical trial was conducted in a total of 160 CHB patients, allocated into two groups of 80 patients each to receive NASVAC or Peg-IFN. The vaccine formulation comprised 100 μg of each HBsAg and HBcAg, and was administered in 2 cycles of 5 doses. The control group received 48 subcutaneous injections of Peg-IFN alfa 2b, 180 μg per dose, every week, for 48 consecutive weeks.
main outcome measureThe primary outcome measure was in relation with the proportion of patients showing reduction of the viral load under the limit of detection (250 copies/mL) after 24 weeks of treatment completion.
resultsSustained control of HBV DNA was significantly more common in NASVAC group (p<0.05) at 24 weeks of follow up. NASVAC-induced increases of alanine aminotransferases (ALT) were detected in 85% patients after 5 nasal vaccinations, although seen in only 30% of patients receiving Peg-IFN. At the end of treatment (EOT) antiviral effect was comparable in both NASVAC and Peg-IFN groups. Clearance of Hepatitis B e antigen (HBeAg) was also more frequent in NASVAC group compared to Peg-IFN recipients. A lower progression to cirrhosis was found in NASVAC group compared to Peg-IFN group.
conclusionNasvac induced a superior reduction of the viral load under the limit of detection compared to Peg-IFN treatment. It is a safe and efficacious finite alternative of antiviral treatment for CHB patients.
trial registrationClinicalTrials.gov NCT 01374308.
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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.