Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Hepatitis B
Interventions
BIOLOGICAL

1018 ISS immunostimulatory oligonucleotide with HBV surface antigen

Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24

Trial Locations (4)

22908

University of Virginia Health System, Nephrology Clinical Research Center, Charlottesville

55430

Twin Cities Clinical Research, Brooklyn Center

78727

Covance, Austin

92626

West Coast Clinical Trials, Costa Mesa

All Listed Sponsors
lead

Dynavax Technologies Corporation

INDUSTRY

NCT00426712 - Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients | Biotech Hunter | Biotech Hunter