Evidence map›Paper›PMID 34832596›Full record

ArticlePathogens (Basel, Switzerland)2021

Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial.

Sheikh Mohammad Fazle Akbar, Mamun Al Mahtab, Julio Cesar Aguilar, Osamu Yoshida, Eduardo Penton, Guillen Nieto Gerardo, Yoichi Hiasa

Abstract read
In one paragraph

Article in Pathogens (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. [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 · 2025
    Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Immune therapies against chronic hepatitis B.Journal of gastroenterology · 2022
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
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

7 authors.

Sheikh Mohammad Fazle AkbarDepartment of Gastroenterology and Metabology, Graduate School of Medicine, Ehime University, Ehime 791-0295, Japan.
Mamun Al MahtabDepartment of Hepatology, Bangabandhu Sheikh Mujib Medical University, BSMMU, Dhaka 1000, Bangladesh.
Julio Cesar AguilarCenter for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
Osamu YoshidaDepartment of Gastroenterology and Metabology, Graduate School of Medicine, Ehime University, Ehime 791-0295, Japan.
Eduardo PentonCenter for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
Guillen Nieto GerardoCenter for Genetic Engineering and Biotechnology, Havana 10600, Cuba.
Yoichi HiasaDepartment of Gastroenterology and Metabology, Graduate School of Medicine, Ehime University, Ehime 791-0295, Japan.ORCID 0000-0003-4117-339X

Funding

Japan Agency for Medical Research and Development (AMED) Grant number 20fk0310103h1904
6 · The paper itself

Abstract

A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.

Indexed as

chronic hepatitis BHBsAg/HBcAg vaccinenasal vaccineNASVACsustained effectstherapeutic vaccine

Identifiers

PMID34832596
PMCPMC8619282

What OpenQuestion holds

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Registered trials

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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.