Evidence map›Paper›PMID 42797641›Full record

ArticleVaccines2026

Nucleos(t)ide Analog-Therapeutic Vaccination Switch: A Novel Approach for Safe and Effective Treatment Discontinuation in HBeAg (-) Chronic Hepatitis B Patients.

Sheikh Mohammad Fazle Akbar, Mamun Al Mahtab, Mohammad Abdur Rahim, Sheikh Mohammad Noor-E-Alam, Musarrat Mahtab, Ahmed Lutful Moben, Rokshana Begum, Dulal Chandra Das, Gerardo Guillen, Osamu Yoshida and 4 more

Abstract read
In one paragraph

Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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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

14 authors.

Sheikh Mohammad Fazle AkbarDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon City 791-0295, Japan.ORCID 0000-0003-4537-3313
Mamun Al MahtabDepartment of Hepatology, Bangladesh Medical University, Dhaka 1000, Bangladesh.ORCID 0000-0003-3728-3879
Mohammad Abdur RahimDepartment of Hepatology, International Medical College, Gazipur 1711, Bangladesh.
Sheikh Mohammad Noor-E-AlamDepartment of Hepatology, Bangladesh Medical University, Dhaka 1000, Bangladesh.
Musarrat MahtabDepartment of Biochemistry, Lab Science Diagnostic, Dhaka 1205, Bangladesh.
Ahmed Lutful MobenDepartment of Hepatology, Kurmitola General Hospital, Dhaka 1206, Bangladesh.
Rokshana BegumDepartment of Hepatology, Shaheed Suhrawardy Medical College, Dhaka 1207, Bangladesh.
Dulal Chandra DasDepartment of Hepatology, Bangladesh Medical University, Dhaka 1000, Bangladesh.
Gerardo GuillenDepartment of Vaccines, Center for Genetic Engineering and Biotechnology, Havana 11600, Cuba.ORCID 0000-0003-3098-0970
Osamu YoshidaDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon City 791-0295, Japan.
Ivan Santos MartinezDepartment of Vaccines, Center for Genetic Engineering and Biotechnology, Havana 11600, Cuba.
Yoichi HiasaDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon City 791-0295, Japan.ORCID 0000-0003-4117-339X
Sakirul KhanGraduate School of Medicine, Oita University, Oita 879-5593, Japan.ORCID 0000-0001-5734-0899
Julio Cesar AguilarDepartment of Pharmacy, Pharmaceutical Technology, and Physical Chemistry, University of Barcelona, 08-007 Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectiveLong-term nucleos(t)ide analog (NUC) therapy effectively suppresses hepatitis B virus (HBV) replication, but it rarely achieves a functional cure and typically requires lifelong administration. A major unmet need in chronic hepatitis B (CHB) is the development of safe and effective strategies to discontinue NUCs without compromising viral control or hepatic safety. This exploratory, randomized pilot study evaluated therapeutic immunization in the context of discontinuation of antiviral therapy in HBeAg-negative CHB.

methodsTwenty-six HBeAg-negative CHB patients receiving long-term therapy with NUCs were randomized to either discontinue NUCs and switch to HeberNasvac (NASVAC), a therapeutic vaccine (n = 13), or receive NASVAC in addition to NUCs (n = 13). Virological, serological, biochemical, and safety parameters were assessed during a 52-week primary follow-up. In particular, ALT and AST were evaluated every 2 weeks during the first 6 months after NUC discontinuation. An extended monitoring period from weeks 96 to 192 was designed to assess virological and biochemical variables.

resultsAt week 48, HBV DNA remained below 2000 IU/mL in 92.3% of patients who discontinued NUCs and received NASVAC and in 100% of those who received both NUCs and NASVAC. During extended follow-up, HBV DNA < 2000 IU/mL persisted in 84.6% and 76.9% of patients in the NUC discontinuation group at weeks 96 and 192, respectively, and in 100% of patients in the continuation group (NASVAC added to NUCs) at both time points. In the first 48 weeks after NUC discontinuation, NASVAC induced a limited but significant decline in serum quantitative HBsAg. Liver function, renal, and hematological parameters remained stable, without significant ALT abnormalities, biochemical exacerbations, fibrosis progression, or severe adverse events during primary or extended follow-up. None of the patients required restarting treatment.

conclusionsNASVAC-based immunotherapy demonstrated durable virological control, a limited but progressive reduction in qHBsAg, and a strong long-term safety profile following the complete withdrawal of antiviral therapy. This exploratory study suggests that NASVAC can be administered in the context of NUC discontinuation with an acceptable short- and long-term safety profile, but controlled trials are required to determine whether therapeutic vaccination contributes independently to sustained off-treatment viral control.

Indexed as

chronic hepatitis BNASVACNUCstherapeutic vaccinetreatment discontinuation

Identifiers

PMID42797641
PMCPMC13611927

What OpenQuestion holds

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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.