Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease

Janssen, Robert S.; Mangoo-Karim, Roberto; Pèrgola, Pablo E.; Girndt, Matthias; Namini, Hamid; Rahman, Sophia; Bennett, Sean; Heyward, William L.; Martin, Jacob T.

doi:10.1016/j.vaccine.2013.05.067

Cited by 67 publications

(51 citation statements)

References 20 publications

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“…51,52 In CKD subjects 18-75 y of age, 3 doses of HBsAg-1018 induced significantly higher, earlier, and more durable seroprotection than 4 double doses of the conventional hepatitis B vaccine. 53 However, HBsAg-1018 was associated with significantly more injection-site tenderness than the conventional vaccine (63.2% -81.8% vs. 15.4% -18.8%). 54 Novel hepatitis B vaccines may provide not only quicker, better and longer seroprotection against HBV, but also improve compliance and reduce costs due to the simplified vaccination schedules.…”

Section: Vaccination Against Hepatitis B Virusmentioning

confidence: 92%

Prophylactic vaccinations in chronic kidney disease: Current status

Grzegorzewska¹

2015

Human Vaccines & Immunotherapeutics

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Section: Vaccination Against Hepatitis B Virusmentioning

confidence: 92%

Prophylactic vaccinations in chronic kidney disease: Current status

Grzegorzewska¹

2015

Human Vaccines & Immunotherapeutics

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“…However, vaccination of the mice with HBsAg plus TLR9-agonist CpG oligonucleotides induced strong antibody production and T-cell responses that cleared HBV viremia (Yang et al, 2014). Furthermore, recent clinical trials have shown that the HBV vaccine with a TLR9 agonist adjuvant (HBsAg-1018) induced significantly higher, earlier, and more durable seroprotection than the conventional HBV vaccine in healthy volunteers and in patients with chronic kidney disease, who are commonly hyporesponsive to HBV vaccines (Heyward et al, 2013; Janssen et al, 2013). …”

Section: Prr Agonists As Adjuvants For Therapeutic Vaccinationmentioning

confidence: 99%

Treatment of chronic hepatitis B with pattern recognition receptor agonists: Current status and potential for a cure

Chang

Guo

2015

Antiviral Research

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Hepatitis B virus (HBV) has been considered to be a “stealth virus” that induces negligible innate immune responses during the early phase of infection. However, recent studies with newly developed experimental systems have revealed that virus infection can be recognized by pattern recognition receptors (PRR), eliciting a cytokine response that controls the replication of the virus. The molecular mechanisms by which interferons and other inflammatory cytokines suppress HBV replication and modulate HBV cccDNA metabolism and function are just beginning to be revealed. In agreement with the notion that the developmental and functional status of intrahepatic innate immunity determines the activation and maturation of the HBV-specific adaptive immune response and thus the outcome of HBV infection, pharmacological activation of intrahepatic innate immune responses with TLR7/8/9 or STING agonists efficiently controls HBV infection in preclinical studies and thus holds great promise for the cure of chronic hepatitis B. This article forms part of a symposium in Antiviral Research on “An unfinished story: from the discovery of the Australia antigen to the development of new curative therapies for hepatitis B.”

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“…Details of the study methods for the phase 3 randomized, observer-blinded, controlled trial of CKD patients, which includes the subgroup of participants with type 2 diabetes mellitus, have been previously described [13]. Briefly, patients 18 to 75 years of age with CKD defined by an estimated glomerular filtration rate (GFR, modification of diet in renal disease [MDRD] formula) ≤45 mL/min/1.73 m 2 with no prior history of hepatitis B vaccination or infection were asked to participate in the trial.…”

Section: Study Design and Participantsmentioning

confidence: 99%