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).
Phase of Trial: Phase I
Latest Information Update: 06 Mar 2017
At a glance
- Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
- Indications Hepatitis B
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Sponsors Dynavax Technologies
- 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.