Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End Stage Renal Disease Patients
- Conditions
- Prevention of Hepatitis B virus (HBV) infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 14.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865
- Registration Number
- EUCTR2010-022372-31-DE
- Lead Sponsor
- Dynavax Technologies Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
A subject must meet all of the following inclusion criteria to participate in the study:
1. enrolled and completed a primary hepatitis B series with HEPLISAV or Engerix-B treatment in DV2-HBV-17
2. be otherwise clinically stable in the opinion of the investigator
3. be able and willing to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
A subject who meets any 1 of the following exclusion criteria is not permitted to participate in the study:
1. received hepatitis B vaccine off-study after enrolling in DV2-HBV-17
2. has a known history of autoimmune disease
3. is unwilling or unable to comply with all the requirements of the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method