Factors influencing response to hepatitis B virus vaccination in hemodialysis patients

Sezer, Sıren; Özdemir, Fatma Nurhan; Güz, Galip; Arat, Z.; Çolak, Turan; Şengül, Şule; Turan, M; Haberal, A; Erdal, Rengin

doi:10.1016/s0041-1345(00)00914-3

Cited by 51 publications

(45 citation statements)

References 5 publications

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“…9 This is of importance, as it is suggested that haemodialysis patients must achieve anti-HB concentrations ≥100 mIU/mL for one year of protection post-vaccination. 10 More patients reported local mild-to-moderate pain at the injection site with ASO4 adjuvanted vaccine than with the aluminum adjuvanted vaccine (40.5% vs 14.7%). However, the incidence of severe pain was minimal and similar for both groups (0.6% for both).…”

Section: Introductionmentioning

confidence: 94%

Improving vaccine delivery using novel adjuvant systems

Pichichero¹

2008

Human Vaccines

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ASO4, a novel adjuvant, contains aluminum hydroxide and monophosphoryl lipid (MPL) (500 mg aluminum hydroxide and 50 mg 3-O-desacyl-4' MPL A). Aluminum hydroxide is an adjuvant known to facilitate vaccine antigen delivery and transport to the draining lymph nodes by creating a 'depot' at the injection site. 2 Like all aluminum adjuvants, aluminum hydroxide helps improve immunogenicity of low molecular weight antigens, which could otherwise clear rapidly from the injection site or draining lymph nodes. 2 MPL, a non-toxic derivative of lipopolysaccharide, improves specific antibody and cell-mediated immune responses to vaccination. 4 With only minimal toxicity, 5 MPL enhances macrophage and B-and Tcell responses, as well as T-helper cell generation. 5,6 AS04 adjuvant has been shown to improve vaccine-induced immune responses in hepatitis B (HBV) and cervical cancer vaccines.In 2004, Boland et al. 7 described a randomized study where healthy subjects received two doses of HBV vaccine with ASO4 adjuvant or three doses of HBV vaccine with aluminum adjuvant. 7 After the first and second dose of ASO4, substantially more subjects were seropositive for anti-HBV antibodies than after the first and third dose of aluminum adjuvanted vaccine (Table 1). Thus, the ASO4 adjuvant provided the potential for an effective two dose HBV vaccine schedule. In addition, after two doses of ASO4 adjuvanted vaccine, geometric mean titers (GMT) were two times higher than those observed with the aluminum adjuvanted vaccine (7,832 mlU/ml vs 3,725 mlU/ml). No serious adverse events (SAEs) related to the vaccinations occurred, and the overall incidence of vaccine-related adverse events (AEs) (e.g., pain, redness and swelling around the injection site) was comparable between groups. 7 For patients undergoing haemodialysis, the Centers for Disease Control recommends stronger or increased doses of HBV vaccine to assure protective immunity. 8 A clinical trial comparing the immune responses of pre-haemodialysis and haemodialysis patients showed four doses of HBV vaccine was more effective with ASO4 adjuvant than with aluminum adjuvant (Table 1). 9 More patients achieved seroprotection at three months (p = 0.005) and remained seroprotected at 36 months with ASO4 adjuvanted vaccine than with aluminum adjuvanted vaccine (p = 0.03, Table 1). 9 At three and seven months post final dose, signficiantly more patients in the HBV-ASO4 adjuvant group had anti-HB concentrations >100 mlU/mL (p < 0.001 and p < 0.04, respectively), and a higher percentage retained these high anti-HB levels at 36 months

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Section: Introductionmentioning

confidence: 94%

Improving vaccine delivery using novel adjuvant systems

Pichichero¹

2008

Human Vaccines

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“…The immunosuppressed status related to renal failure could be involved in the low rates of response of hemodialyzed patients (19). It is of importance, however, that since vaccination programs have been initiated with renal failure patients, the incidence of HBV disease has decreased considerably.…”

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confidence: 99%

Anti-HBs Cellular Immune Response in Kidney Recipients before and 4 Months after Transplantation

Aguilar

Renoult

Jarrosson

et al. 2003

Clin Vaccine Immunol

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Patients with renal failure represent a population at risk for hepatitis B, since only 50 to 60% of them develop protective humoral responses after vaccination. As this could be due to an altered regulation of cellular immune responses, the objectives of the present study were to evaluate the proliferative abilities of lymphocytes from patients with chronic renal failure after stimulation in vitro with a mitogen (pokeweed mitogen [PWM]) or HBsAg. In order to differentiate between the immunodeficiency associated with renal failure and that due to immunosuppression posttransplantation, the same subjects were tested before and 4 months after kidney transplantation. The lymphoproliferation assay used was performed by flow cytometry, which is based on sequential analysis of the cell cycle and which allows analysis of cytokine production. Serologically, the group of 36 patients tested comprised 22% nonresponders, 30% poor responders, and 48% responders. Lymphocyte growth was observed for all patients after stimulation with PWM, indicating that these cells had the capacity to proliferate in vitro. The level of lymphoproliferation in response to PWM was significantly reduced after transplantation, yet both before and after transplantation, all serologic nonresponders developed cellular responses to at least two vaccines. No correlation between humoral and cellular responses was shown. Proliferating cells were lymphocytes, which mostly secreted interleukin 4 (IL-4) and IL-10 for the three serologic groups. This study suggests that even when repeated vaccination fails to induce significant antibody levels in patients with renal failure, specific HBs cellular responses develop, and these may prove to be efficient in protecting these patients against hepatitis B.

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“…Studies in hemodialysis patients have shown anti-HBs antibody concentrations ≥100 mIU/ml following vaccination to be predictive of long-term persistence of circulating antibodies. [12][13][14] Indeed, this cut-off is considered to be the best surrogate marker of long-term seroprotection in immunocompromised patients by a number of vaccination advisory bodies. 15,16 Results of an earlier study of the HB-AS02 vaccine in a smaller group of healthy volunteers also found all subjects to be seroprotected after two vaccine doses.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02_V) in healthy adults

Beran¹,

Hobzová²,

Wertzova³

et al. 2010

Human Vaccines

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Factors influencing response to hepatitis B virus vaccination in hemodialysis patients

Cited by 51 publications

References 5 publications

Improving vaccine delivery using novel adjuvant systems

Improving vaccine delivery using novel adjuvant systems

Anti-HBs Cellular Immune Response in Kidney Recipients before and 4 Months after Transplantation

Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02_V) in healthy adults

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Factors influencing response to hepatitis B virus vaccination in hemodialysis patients

Cited by 51 publications

References 5 publications

Improving vaccine delivery using novel adjuvant systems

Improving vaccine delivery using novel adjuvant systems

Anti-HBs Cellular Immune Response in Kidney Recipients before and 4 Months after Transplantation

Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults

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Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02_V) in healthy adults