Recombinant Hepatitis B Vaccine Adjuvanted With AS04 in Dialysis Patients: A Prospective Cohort Study

Fabrizi, Fabrizio; Tarantino, A; Castelnovo, Claudia; Martin, Paul; Messa, P.

doi:10.1159/000368534

Cited by 23 publications

(13 citation statements)

References 29 publications

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“…Recent evidence has been gathered on adjuvanted recombinant HB vaccines (HBVAS04) (46,47) or third-generation vaccines (48) (recombinant HBV vaccines expressed in mammalian cells containing S/Pre-S antigens) in chronic kidney disease population. Trials comparing efficacy and safety of adjuvanted HBVAS04 vaccine versus recombinant vaccine (with greater doses) in patients with chronic kidney disease are under way.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Fabrizi

Donato

2017

Hepat Mon

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Context: The immunogenicity of the hepatitis B virus vaccine is reduced in patients with renal failure compared with the nonuraemic population. A variety of approaches have been suggested to improve the immune response in uraemic population including an increase in dose of the hepatitis B vaccine. Objective: To compare the efficacy and safety of hepatitis B vaccine schedules based on greater versus standard doses of HB vaccine in patients with chronic kidney disease stages 3 -5. Evidence Acquisition: We carried out a systematic review of the medical literature with a meta-analysis of randomized trials comparing seroprotection rates after greater vs. standard doses of the HB vaccine. The odds ratio to obtain seroprotection among patients who received greater (study group) vs. standard (control group) doses was the end-point of interest. We used a random-effects approach, as described by DerSimonian and Laird, with heterogeneity and subgroup analyses. Results: We retrieved 11 clinical trials (n = 870 unique patients); 2 (n = 141 patients) and 8 studies (n = 689) included CKD patients on pre-dialysis and dialysis stage, respectively. Three trials (n = 368 patients) employed plasma-derived vaccine; 8 (n = 502) adopted recombinant vaccine. Aggregation of study results (n = 10 studies) showed that the seroprotection rate (short-term follow-up) towards HB virus was higher among patients receiving greater than standard doses of vaccine [pooled OR, 2.10, 95% confidence intervals, 1.15 -3.82]. The P-value was 0.0001 for our test to study heterogeneity. The seroprotection rate towards HBV was much greater in the subset of trials (n = 2) based on plasma-derived vaccine (OR, 3.78; 95% CI, 2.35; 6.07), and no heterogeneity was found (NS). In the subset of RCTs (n = 8 studies), the seroprotection rate was higher among patients receiving greater doses of vaccine towards HBV, OR, 2.01 (95% CI, 0.92; 4.39), with significant heterogeneity (P = 0.002). Tolerance was satisfactory and no dropouts due to side effects were reported. Conclusions: Vaccine schedules based on greater than standard doses of HB vaccine offer higher immunogenicity in patients with chronic kidney disease. These results support the current recommendations to give higher doses of HBV vaccine to susceptible dialysis population in order to increase the sero-protection rate. Further research is needed to assess whether these findings apply to HB vaccines provided with novel adjuvants.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Fabrizi

Donato

2017

Hepat Mon

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“…Новая рекомбинантная вакцина против HBV, содержащая в своем составе AS04 в качестве адъюванта (HBV-AS04), отличается более высокой иммуногенностью при применении в указанной группе вакцинируемых лиц. Отмечается, что переносимость HBV-AS04 была удовлетворительной, проявление побочного действия наблюдалось в незначительной степени [83].…”

Section: адъювантные системыunclassified

General Characteristics of Adjuvants and Their Mechanism of Action (Part 1)

Алпатова¹,

Авдеева²,

Лысикова³

et al. 2020

Biopreparaty. Profilaktika, diagnostika, lechenie

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One of priority issues of the present-day healthcare system is development of new vaccines and improvement of existing ones due to decreasing immunocompetence of the population, emergence of new infections and reemergence of old ones which were previously thought to be under control. Adjuvants have proven to be integral and important components of modern vaccines, as they enhance immune response to the vaccine antigen. However, despite a lot of effort put into their development, only a small number of adjuvants are currently used in clinical practice.The aim of the study was to systematise literature data on the adjuvants’ mechanisms of action, their specific structure, composition, and stimulation effects that mediate their immunoadjuvant properties. The paper summarises data on adjuvants used as components in licensed vaccines, describes their characteristics, analyses molecular mechanisms of their action in order to establish correlation between their structure and activity, which is important for the development of more efficacious and safe adjuvants. The paper cites advanced developments aimed at enhancing stimulation effects of existing adjuvants. It concludes by stating that the key research area aimed at improving vaccination efficacy is the study of mechanisms that contribute to the development of effective protection against infectious agents, as well as analysis of how to use adjuvants to stimulate the body’s defensive mechanisms, primarily by impacting the innate immunity.

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“…По этим причинам предпринимаются усилия по выявлению условий, которые могли бы повысить иммуногенность применяемой вакцины или разработать новую рецептуру более иммуногенной ГВ-вакцины. Добавление иммуностимуляторов к вакцине также предполагалось в качестве стратегии повышения эффективности вакцинации у пациентов на ГД [72][73][74].…”

Section: таблицаunclassified

Population-Genetic Research of the VDR Gene Polymorphism

Volkov¹,

Цуркан²

2019

FCM

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Recombinant Hepatitis B Vaccine Adjuvanted With AS04 in Dialysis Patients: A Prospective Cohort Study

Cited by 23 publications

References 29 publications

Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

General Characteristics of Adjuvants and Their Mechanism of Action (Part 1)

Population-Genetic Research of the VDR Gene Polymorphism

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