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A phase 1, randomized, observer-blind, dose-escalating study in adult end-stage renal failure patients to explore the safety, tolerability, pharmacokinetics and immune response to recombinant hepatitis B virus surface antigen (rHBsAg) co-administered with Dynavax immunostimulatory phosphorothioate oligodeoxyribonucleotide (1018 ISS).

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A phase 1, randomized, observer-blind, dose-escalating study in adult end-stage renal failure patients to explore the safety, tolerability, pharmacokinetics and immune response to recombinant hepatitis B virus surface antigen (rHBsAg) co-administered with Dynavax immunostimulatory phosphorothioate oligodeoxyribonucleotide (1018 ISS).

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Adjuvanted Hepatitis-B vaccine (Recombinant)-Dynavax (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Dynavax Technologies

    • Most Recent Events

    • 20 Jul 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 28 Jul 2009 Actual number of patients (42) added as reported by ClinicalTrials.gov
    • 21 Feb 2007 New trial record.

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