More viral mutants, less HBsAg clearance? One size may not fit all

Tseng, Tai‐Chung; Yang, Hung‐Chih

doi:10.1136/gutjnl-2016-313027

Gut

2016

DOI: 10.1136/gutjnl-2016-313027

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More viral mutants, less HBsAg clearance? One size may not fit all

Tai‐Chung Tseng

Hung‐Chih Yang

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Cited by 2 publications

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“…We thank Dr Tseng and colleagues for their interest1 in our recent study that identified a negative association between the presence of hepatitis B virus (HBV) basal core promoter (BCP)/precore (PC) and precore (PC) variants mutants at baseline and lower likelihood of hepatitis B surface antigen (HBsAg) loss among 157 subjects with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) treated for 4 years with tenofovir therapy. 2–4 The likelihood of HBsAg loss was 41% in subjects with wild-type (WT) sequence at the BCP/PC loci versus 3% in subjects with detectable BCP/PC variants (next generation sequencing (NGS), Illumina MiSeq—threshold for detection >1%).…”

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confidence: 99%

Reply: ‘More viral mutants, less HBsAg clearance? One size may not fit all'

Thompson

Locarnini

Revill

2016

Gut

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confidence: 99%

Reply: ‘More viral mutants, less HBsAg clearance? One size may not fit all'

Thompson

Locarnini

Revill

2016

Gut

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New Russian Trivalent Hepatitis B Vaccine (Bubo<sup>®</sup>-Unigep): Clinical Study Results

Borisova,

Maksvitis,

Ivanov

et al. 2023

Epidemiology and Vaccinal Prevention

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Relevance. Currently, there is no registered vaccine against the hepatitis B virus (HBV) mutant G145R worldwide, which justifies the need to develop a new generation of vaccines due to large-scale immunization against hepatitis B and the accumulation of escape mutants of the virus.The aim of the study was a comparative assessment of the immunogenicity, reactogenicity and safety of Bubo®-Unigep (trivalent hepatitis B recombinant yeast vaccine) and the drug Hepatitis B recombinant yeast vaccine.Materials and methods. To assess the main characteristics of the new trivalent vaccine Bubo®-Unigep (CJSC NPC «COMBIOTECH»), a doubleblind, comparative, randomized, multicenter clinical trial was conducted in two parallel groups in previously unvaccinated individuals in an adult healthy population (n = 166) according to a protocol developed by the contract research organization «R&D Pharma».Results. The assessment of hematological and biochemical parameters during screening and the administration of vaccine preparations showed that in the individuals included in the study, the studied indicators were within the boundaries of the normal range. According to the criteria for assessing safety and efficacy, both drugs had low reactogenicity, no serious adverse events were registered. The results of a comparative analysis of the concentrations of antibodies to HBsAg determined after a full course of immunization with Bubo®-Unigep vaccine or recombinant yeast Hepatitis B vaccine showed that both drugs effectively induced a humoral immune response (anti-HBs) with seroprotection rates of 96.3% and 92.6%.Conclusion. The inclusion of the relevant HBV serotypes (ay and ad) and the mutant antigen G145R in the composition of the new polyvalent vaccine Bubo®-Unigep contributes to the expansion of the spectrum of specificity of the immune response, and, consequently, more effective vaccination of hepatitis B.

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More viral mutants, less HBsAg clearance? One size may not fit all

Cited by 2 publications

References 4 publications

Reply: ‘More viral mutants, less HBsAg clearance? One size may not fit all'

Reply: ‘More viral mutants, less HBsAg clearance? One size may not fit all'

New Russian Trivalent Hepatitis B Vaccine (Bubo<sup>®</sup>-Unigep): Clinical Study Results

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