Immunogenicity and safety of an investigational AS02v-adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials

Tielemans, Christian; Vlasak, Jiri; Kosa, D.; Billiouw, Jean-Marie; Verpooten, Gert A.; Mezei, Ilona; Ryba, M; Peeters, Patrick; Mat, Olivier; Jadoul, Michel; Polakovič, Vladimír; D'haene, Michel; Treille, S.; Kuriyakose, Sherine; Leyssen, Maarten; Houard, Sophie; Surquin, Murielle

doi:10.1016/j.vaccine.2010.12.009

Cited by 29 publications

(19 citation statements)

References 22 publications

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“…AS02-adjuvanted hepatitis B vaccine has been studied in patients with renal insufficiency and resulted in higher rates of seroconversion and anti-HBs titres than those of unadjuvanted vaccine. 98 …”

Section: Strategies To Improve Vaccine Efficacymentioning

confidence: 99%

Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1

Whitaker

Rouphael

Edupuganti

et al. 2012

The Lancet Infectious Diseases

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HIV and hepatitis B virus co-infection leads to substantially increased morbidity and mortality compared with either infection alone. Immunisation with hepatitis B virus vaccine is the most effective way to prevent the infection in people with HIV; however, these patients have decreased vaccine responses and a short duration of protection compared with immunocompetent individuals. Control of HIV replication with highly active antiretroviral therapy and increased CD4 cell counts are associated with improved immune responses to hepatitis B vaccination. New vaccination strategies, such as increased vaccine dose, use of the intradermal route, and addition of adjuvants, could improve response rates in adults with HIV.

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Section: Strategies To Improve Vaccine Efficacymentioning

confidence: 99%

Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1

Whitaker

Rouphael

Edupuganti

et al. 2012

The Lancet Infectious Diseases

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“…A widely investigated adjuvant combinations containing 2 adjuvant components are the AS series of adjuvants, such as AS01 (liposomes containing deacylated MPL and QS21) [451], AS02 (an oil-in-water emulsion containing deacylated MPL and QS21) [452,453], and AS05 (liposomes containing aluminum hydroxide, deacylated MPL and QS21 in a weight ratio of 10:1:1) [454]. These systems seem to be effective in enhancing both humoral and cellular immunogenicity of different types of antigens in human subjects [452,455] and can be more effective than commercial vaccines for certain patient populations 453.…”

Section: Adjuvant Combinationsmentioning

confidence: 99%

Selection of Adjuvants for Enhanced Vaccine Potency

Wang¹,

Singh²

2011

WJV

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“…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%

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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Immunogenicity and safety of an investigational AS02v-adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials

Cited by 29 publications

References 22 publications

Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1

Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1

Selection of Adjuvants for Enhanced Vaccine Potency

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

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