An outbreak of fulminant hepatitis B in immunocompromised hemodialysis patients

Igaki, Naoya; Nakaji, Miyuki; Moriguchi, Rintarou; Akiyama, Hiroyuki; Tamada, Fumihiko; Oimomi, M; Goto, Takeo

doi:10.1007/s00535-003-1180-1

Cited by 27 publications

(29 citation statements)

References 39 publications

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“…In addition, numerous in vivo and in vitro experiments have shown that the impaired response to the HBV vaccine in uremic individuals has been related to additional factors: a lower activation of T-lymphocytes (naïve CD4) to helper cells by overproduction of TNF-α, re- According to our systematic review, reinforced schedules of the HB vaccine enhance the response rate in uraemic patients. This phenomenon is particularly clear 6 Hepat Mon. 2017; 17 (7):e44179.…”

Section: Discussionmentioning

confidence: 98%

“…On the contrary, prevalence and incidence rates of HBV remain high within dialysis facilities of the developing world (5). In addition, outbreaks of the HBV infection among patients undergoing long-term hemodialysis continue to be reported in industrialized countries (6). To prevent transmission of HBV in haemodialysis units, numerous measures have been performed including the screening of blood for the hepatitis B surface antigen (HBsAg), the decline in the number of blood transfusions, and the implementation of universal and specific measures within dialysis rooms, as recommended by the centers for disease control and prevention (CDC, Atlanta, Georgia, USA) (7).…”

Section: Contextmentioning

confidence: 99%

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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: 98%

Section: Contextmentioning

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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Section: Hbvmentioning

confidence: 99%

“…Up to 60% of infected patients on haemodialysis are not able to clear the virus and therefore become chronic HBV carriers [92]. Moreover, even though patients are vaccinated and appropriate measures to prevent transmission of the virus have been put in place, HBV outbreaks in dialysis centres still occur [93,94].In the normal healthy population, long-term protection relies on immune memory in humans reaching anti-HBs concentrations ≥10 mIU/mL post vaccination.For immunocompromised individuals, protection against HBV infection relies more on circulating antibodies [95]. Studies in haemodialysis patients showed that many patients with anti-HBs levels between 10 and 100 mIU/mL did not retain protective antibody level of ≥10 mIU/mL one year post vaccination.…”

mentioning

confidence: 99%

Designing Vaccines against Human Papillomavirus and Hepatitis B Virus: Similarities and Differences for Preventable Viral Infections and role of AS04 Adjuvant System in Addressing Specific Challenges

Garçon¹

2012

J Vaccines Vaccin

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IntroductionSeveral intracellular pathogens can establish long-lasting chronic infections and may lead to clinical disease. Two examples of such pathogens are the Human papillomavirus (HPV) and the Hepatitis B virus (HBV). Immunological mechanisms are involved both in the establishment and maintenance of the tolerance to these infections. Chronic infections and diseases are the results of a delicate interplay between the pathogen's actions to survive in the host and the attempts of the immune system to eradicate it.HPV is one of the most common chronic viral infections in humans. The virus consists of circular, double stranded DNA and has no envelope. Approximately 130 different HPV types have been identified so far [1] and about 40 of these infect the human genital tract, including 15 of types considered as oncogenic [2]. It is estimated that up to 80% of women will acquire a HPV infection in their lifetime [3]. Cervical HPV infections are asymptomatic; although most of them clear spontaneously and only 5-10% will become persistent infection possibly leading to the development of clinical pre-cancerous lesions and cancer.Upon natural infection, HPV remains at the site of infection, evades the immune system, and does not reliably induce protective immunity as the virus does not kill infected cells and hence neither inflammation nor release of danger signals to be recognised by the immune system is triggered. As a result, new infections and re-infection can occur [4]. A prophylactic HPV vaccine should therefore induce a better immune response than natural infection by overcoming the challenges due to the pathogen (i.e. have the ability to block the virus at the site of entrance), hence induce higher level of antibodies, and provide longterm protection [4].HBV infects hepatocytes and consists of a double-stranded circular DNA genome, an outer envelope protein (HBsAg), an inner nucleocapsid protein, (HBcAg), and a soluble small molecular weight protein (HBeAg) produced by the core gene. The HBsAg envelope protein can be shed and is also found as a non-infectious self-assembling tubular or spherical particle in the bloodstream of infected patients [5]. Overall eight genotypes of HBV are known [6,7]. AbstractPathogen characteristics and the mechanism of host/pathogen interaction play a key role in design, formulation, and development of vaccines. Here we present the experience of GSK Bio in developing two vaccines with a novel Adjuvant System (AS04) against two viral infections, Human papillomavirus (HPV) and Hepatitis B virus (HBV), that have some similarities and many differences.Developing a vaccine against HPV is difficult because the virus remains local, evades the immune system, and does not induce a reliable long lasting protection upon natural infection. Vaccination of pre-haemodialysis and haemodialysis patients against hepatitis B represents a challenge as well, because these patients are immunocompromised and develop a reduced and short lasting immune response to administration of conventional HBV vaccine...

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“…The implementation of routine screening of blood derived products, and infection control practices including universal precautions, separate rooms and separate machines for HBsAg positive patients have sharply reduced the incidence of HBV infection in dialysis units [2,3], even if outbreaks continue to occur in chronic haemodialysis centers [4,5]. In addition, HBV vaccination has been recommended for all sero-negative dialysis members and staff members since the early 1980s [2,3].…”

Section: Introductionmentioning

confidence: 99%

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

Fabrizi

Tarantino

Castelnovo

et al. 2015

Kidney Blood Press Res

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Background/Aims: Patients undergoing maintenance dialysis have an unsatisfactory response to vaccination, including to hepatitis B vaccine. A recombinant HB vaccine containing a new adjuvant system AS04 (HBV-AS04) has been recently developed; a few data exist on the immunogenicity and safety of HBV-AS04 among patients undergoing regular dialysis. All hepatitis B virus-seronegative patients with undetectable antibody against HBsAg undergoing maintenance dialysis at two units were prospectively included. Methods: Patients received four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 0,1,2, and 3. Anti-HB surface antibody concentrations were measured at intervals of 1, 2, 3, 4, and 12 months. Univariate and multivariate analyses determined which parameters predicted immunologic response to HBV-AS04 vaccine. Results: 102 patients were enrolled and 91 completed the study. At completion of the vaccination schedule, using per-protocol analysis, 76 of 91 (84%) had antibody titers ≥10 mIU/mL with anti-HBs geometric antibody concentrations (GMCs) of 385.25 mIU/mL. The sero-protection rate at month 12 was 84% (48/57) with lower GMCs (62.74 mIU/mL, P<0.0001). Multivariate analysis revealed a detrimental role of age on the immune response to HB-AS04 vaccine (F Ratio, 4.04; P<0.04). Tolerance to HBV-AS04 was good and only minor side-effects were observed. Conclusions: HBV-AS04 vaccine was highly immunogenic in our cohort of patients on maintenance dialysis even if a significant number of non-responders is still present. Prospective studies with HBV-AS04 on larger study groups and with longer follow-ups are under way.

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An outbreak of fulminant hepatitis B in immunocompromised hemodialysis patients

Cited by 27 publications

References 39 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

Designing Vaccines against Human Papillomavirus and Hepatitis B Virus: Similarities and Differences for Preventable Viral Infections and role of AS04 Adjuvant System in Addressing Specific Challenges

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

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