Evidence map›Paper›PMID 35062707›Full record

ArticleVaccines2021

The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial.

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

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 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
2.6field-weighted citation impact, top 10% 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.

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, 19 citations in OpenAlex.

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

8 authors at 4 institutions in 3 countries.

Sheikh Mohammad Fazle AkbarDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon 791-0295, Japan.ORCID 0000-0003-4537-3313
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, Ehime University Graduate School of Medicine, Toon 791-0295, Japan.
Sakirul KhanDepartment of Microbiology, Faculty of Medicine, Oita University, Oita 879-5593, Japan.ORCID 0000-0001-5734-0899
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, Ehime University Graduate School of Medicine, Toon 791-0295, Japan.ORCID 0000-0003-4117-339X
Centro de Ingeniería Genética y Biotecnología · CUEhime University · JPBangladesh Medical University · BDOita University · JP

Funding

Japan Agency for Medical Research and Development (AMED) Grant number 20fk0310103h1904Japan Agency for Medical Research and Development (AMED) Grant number 20fk0310103h1905
6 · The paper itself

Abstract

The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis.

Indexed as

chronic hepatitis Bfollow-upHBsAg/HBcAg vaccinenasal vaccineNASVACtherapeutic vaccine

Identifiers

PMID35062707
PMCPMC8778341
OpenAlexW4206105266

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.