Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients

Kong, Norella C T; Beran, Jiřı́; Kee, Swee Ann; Miguel, José Luís; Sánchez, Carmen; Bayas, José M.; Vilella, Àngels; Juanes, J.R. de; Arrazola, P.J.; Calbo-Torrecillas, F.; Novales, E. Lopez de; Hamtiaux, Virginie; Lievens, Marc; Stoffel, M.

doi:10.1111/j.1523-1755.2005.00689.x

Cited by 187 publications

(44 citation statements)

References 15 publications

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“…Also, the antigens might be different since one vaccine includes not only the small HbsAg but all three subtypes of HbsAg (small, middle, and large) with the benefit of a better immune reaction and similar side effects [77]. In addition, a vaccine with a special adjuvant (AS04) is available that was mainly designed for immunosuppressed individuals [78]. For healthy adults, a 20 µg dose without adjuvant AS04 seems to be sufficient.…”

Section: Indications For Vaccination In Elite Athletesmentioning

confidence: 99%

Vaccination in Elite Athletes

Гартнер

Meyer

2014

Sports Med

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Public health vaccination guidelines cannot be easily transferred to elite athletes. An enhanced benefit from preventing even mild diseases is obvious but stronger interference from otherwise minor side effects has to be considered as well. Thus, special vaccination guidelines for adult elite athletes are required. In most of them, protection should be strived for against tetanus, diphtheria, pertussis, influenza, hepatitis A, hepatitis B, measles, mumps and varicella. When living or traveling to endemic areas, the athletes should be immune against tick-borne encephalitis, yellow fever, Japanese encephalitis, poliomyelitis, typhoid fever, and meningococcal disease. Vaccination against pneumococci and Haemophilus influenzae type b is only relevant in athletes with certain underlying disorders. Rubella and papillomavirus vaccination might be considered after an individual risk–benefit analysis. Other vaccinations such as cholera, rabies, herpes zoster, and Bacille Calmette–Guérin (BCG) cannot be universally recommended for athletes at present. Only for a very few diseases, a determination of antibody titers is reasonable to avoid unnecessary vaccinations or to control efficacy of an individual’s vaccination (especially for measles, mumps, rubella, varicella, hepatitis B and, partly, hepatitis A). Vaccinations should be scheduled in a way that possible side effects are least likely to occur in periods of competition. Typically, vaccinations are well tolerated by elite athletes, and resulting antibody titers are not different from the general population. Side effects might be reduced by an optimal selection of vaccines and an appropriate technique of administration. Very few discipline-specific considerations apply to an athlete’s vaccination schedule mainly from the competition and training pattern as well as from the typical geographical distribution of competitive sites.

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Section: Indications For Vaccination In Elite Athletesmentioning

confidence: 99%

Vaccination in Elite Athletes

Гартнер

Meyer

2014

Sports Med

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“…Such immunologic response was lower than that observed by Tong et al . in their Fendrix arm (91%) [12]. The study by Tong et al .…”

Section: Discussionmentioning

confidence: 99%

“…Despite their extraordinary efficacy second-generation HB vaccines can result in immunization failure which can be explained by numerous variables including renal failure and immuno-suppression. Various options are currently available to address immunization failure in patients with end-stage renal disease; second-generation recombinant vaccines formulated with adjuvants [12,13,16], or manufactured by a modified process [17] or third-generation HB vaccines [18] look promising.…”

Section: Discussionmentioning

confidence: 99%

“…Various approaches have been used to improve the immunogenicity of second-generation (or recombinant) HB vaccine in chronic uraemia, including reinforced HB vaccine schedules [6,7], concomitant use of immuno-modulators [8,9], intradermal administration of HB vaccine [10], and vaccination of chronic kidney disease patients at pre-dialysis stage [11], among others. A recombinant HB vaccine containing a new adjuvant system (AS04) has been recently developed but the evidence on the immune response of HBV-AS04 in dialysis population is limited [12,13]. HBV-AS04 is a novel adjuvant system containing aluminium salt and and 3- O -desacyl-4_-monophosphoryl lipid A (MPL); it has been suggested that the adjuvant system AS04 could stimulate cellular and humoral responses via an increased antigen-presenting capacity through upregulation of the CD86 molecule and/or via an increased synthesis of cytokines.…”

Section: Introductionmentioning

confidence: 99%

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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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“…There is also a need for therapeutic vaccines for those with chronic HBV infection, with alum-based HBV vaccines being ineffective in this context[6]. Attempts to improve HBV vaccine potency for poor responder populations have included use of double-dose HBsAg vaccines[7], use of preS antigens[8] and use of alternative adjuvants such as AS04, a combination of alum and monophosphoryl lipid A (Fendrix®, GlaxoSmithKline, UK) approved in Europe for renal hemodialysis patients [9, 10] and an immunostimulatory oligonucleotide adjuvant (Heplisav®, Dynavax, USA) in clinical development in the US [11, 12]. …”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study

Gordon

Kelley

Heinzel

et al. 2014

Vaccine

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There is a need for additional safe and effective human vaccine adjuvants. Advax is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9–139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0–266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3–12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482

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Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients

Abstract: The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid, enhanced, and longer seroprotection to these immunocompromised patients at risk for HB infection.

Cited by 187 publications

References 15 publications

Vaccination in Elite Athletes

Vaccination in Elite Athletes

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

Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study

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