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1018 ISS immunostimulatory oligonucleotide with HBV surface antigen

Phase 1

Hepatitis B | Monoclonal antibody | Infectious Disease |Dynavax Technologies Corporation|Last Updated: Mar 20, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

1018 ISS immunostimulatory oligonucleotide with HBV surface antigen · 1 trial · 1 indication

Phase 1 1
NCT00426712Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure PatientsHepatitis B
COMPLETED42 Analytics
PHASE1COMPLETED
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of adverse events and local and systemic reaction rates
28 weeks

Secondary Endpoints

Portion of subjects who have a seroprotective immune response (anti-HBsAg antibody ≥ 10 mIU/mL)
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLow dose
2EXPERIMENTALMiddle dose
3EXPERIMENTALHigh dose
4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
1018 ISS immunostimulatory oligonucleotide with HBV surface antigenBIOLOGICALIntramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
Hepatitis B Vaccine (Recombinant)BIOLOGICALIM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Willing and able to give written informed consent * Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis * Body ...

Countries:United States
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