Immunogenicity of a yeast-derived hepatitis B vaccine in hemodialysis patients

Bruguera, Miguel; Cremades, M; Rodicio, J. L.; Alcázar, J Riquelme; Oliver, Arturo; Rio, Gerardo Del; Esteban, Rafael

doi:10.1016/0002-9343(89)90528-7

Cited by 32 publications

(17 citation statements)

References 11 publications

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“…DRB1*0301, DRB1*0701, and DQB1*0201 [5,8,9] were shown to have a higher prevalence in non-responders, whereas other antigens (DRB1*0101, *1301, *1501, and DPB1*0401) seem to mediate strong immune responses [9][10][11][12] . Higher age, obesity, male gender, smoking, and chronic dialysis are risk factors for a non-/ low-responsiveness [8,9,[13][14][15] .…”

Section: Resultsmentioning

confidence: 99%

T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

Weihrauch¹,

Bergwelt‐Baildon²,

Kandic³

et al. 2008

WJG

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CONCLUSION:Our data suggest that there is no general immune deficiency in non-/low-responders. Thus, we hypothesize that the induction of anti-HBsAg responses by vaccination is significantly dependent on the pre-existing T cell repertoire against the specific antigen rather than the presence of a general T cell defect. INTRODUCTIONWorldwide, hepatitis B virus (HBV) infections are a growing problem with a high prevalence of over 8% hepatitis B surface antigen (HBsAg) positive individuals in Africa, South America, parts of Eastern Europe, South Asia, and Canada [1] . It is estimated that approximately 350 million people are chronic carriers of HBV with 1-1.5 million dying from liver cirrhosis and primary liver cancer [2] . Nowadays, protective repeated vaccinations with recombinant HBsAg are not only recommended to all health care workers and travellers, but have recently been included in the childhood and adolescence immunization schedule. Hepatitis B vaccinations prevent HBV infections as well as its complications in most of the vaccines [3,4] . However, 5% to 10% fail to produce protective anti-HBsAg titers after three vaccinations irrespective of the source of the antigen, which is a problem not only for health care workers, and represents a major medical as well as economic challenge [5][6][7] . Low-(HBsAg titer 10-99 kU/L) or Abstract AIM: To evaluate, whether humoral hepatitis-B-vaccine non-responders also fail to mount a T cell response and to compare these results to normal vaccines. RAPID COMMUNICATION T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

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Section: Resultsmentioning

confidence: 99%

T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

Weihrauch¹,

Bergwelt‐Baildon²,

Kandic³

et al. 2008

WJG

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“…Two hepatitis B infections occurred over the follow-up in 1 trial (21), no SAEs were observed in the others (23)(24)(25)(29)(30)(31). No dropouts due to side effects were reported.…”

Section: Side-effectsmentioning

confidence: 99%

“…A total of 11 studies met the inclusion criteria (21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). A complete list of the 431 reports reviewed is available (see supplementary File 2).…”

Section: Literature Reviewmentioning

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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“…Compared to adults with normal immune status, pre-haemodialysis and haemodialysis patients have a suboptimal response to standard HBV vaccination with aluminium adjuvanted vaccines, because their immune system is impaired. These patients require double dosage of HBV vaccine and a four-dose schedule, followed by frequent boosters to maintain protection [86][87][88][89][90]. For that reason GSK Bio developed an alternative HBV vaccine formulation targeted to this specific population [91].…”

Section: Hbvmentioning

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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Immunogenicity of a yeast-derived hepatitis B vaccine in hemodialysis patients

Cited by 32 publications

References 11 publications

T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

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

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