Prevention of hepatitis B virus (HBV) infection MedDRA version: 14.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: HEPLISAV™
Product Code: 1018 ISS-HBsAg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Hepatitis B Surface Antigen
CAS Number: N/A
Current Sponsor code: HBsAg
Other desc
Sponsors
Dynavax Technologies Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 years of age or older • has loss of renal function and is receiving hemodialysis treatment • is not seroprotected against hepatitis B (has anti-HBs =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • if female, is pregnant, breastfeeding, or planning a pregnancy • has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV through a mode other than hemodialysis; for example, current intravenous drug use, unprotected sex with known HBV or HIV positive partner • has known history of autoimmune disease, including • Neuroinflammatory disorders: optic neuritis, multiple sclerosis,demyelinating disease, transverse myelitis, Guillain-Barre syndrome, myasthenia gravis, encephalitis, neuritis, Bell's palsy • Musculoskeletal disorders: systemic lupus erythematosus, cutaneous lupus, Sjogren's syndrome, scleroderma, dermatomyositis, polymyositis, rheumatoid arthritis, juvenile rheumatoid arthritis, polymyalgia rheumatica, reactive arthritis, psoriatic arthropathy, ankylosing spondylitis, spondyloarthropathy • Gastrointestinal disorders: Chron's disease, ulcerative colitis, celiac disease • Metabolic disease: autoimmune thyroiditis, Grave's or Basedow's disease, Hashimoto thyroiditis, type 1 diabetes mellitus, Addison's disease • Skin disorders: psoriasis, vitiligo, Raynaud's phenomenon, erythema nodosum, autoimmune bullous skin diseases • Others: anti-neutrophil cytoplasmic vasculitis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, antiphospholipid syndrome, temporal arteritis, Behcet's syndrome, pernicious anemia, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune glomerulonephritis, autoimmune uveitis, autoimmune cardiomyopathy, renal vasculitis, sarcoidosis, Stevens-Johnson syndrome, Wegener's granulamatosis • has a history of sensitivity to any component of study vaccines • has current condition other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results • is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin • has uncontrolled diabetes • is unwilling or unable to comply with all the requirements of the protocol • has received a kidney transplant previously that is still functioning and requires anti-rejection medication • has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period • has received the following prior to the first injection: • 3 days: intravenous iron • 21 days: any inactivated virus or bacterial vaccine • 28 days: o any live virus or bacterial vaccine o systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids o granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-simulating factor (GM-CSF) o any other investigational medicinal agent • At any time: o an injection of DNA plasmids or oligonucleotides o investigational hepatitis B vaccine o intradermal hepatitis B vaccine, if given as primary vaccine series
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to compare the immune response of HEPLISAV with Engerix-B and Fendrix as measured by seroprotection rate (SPR) defined as the percentage of subjects with a serum antibody concentration to hepatitis B surface antigen (anti-HBs) = 10 mIU/mL in subjects at 4 weeks after the booster injection;Secondary Objective: • to evaluate the safety of HEPLISAV compared with Engerix-B and Fendrix in patients with end stage renal disease (ESRD) on hemodialysis • to compare the immunogenicity of HEPLISAV with Engerix-B and Fendrix as measured by SPR at Week 12 following booster injection • to compare the immunogenicity of HEPLISAV with Engerix-B and Fendrix as measured by percentage of subjects with anti-HBs = 100 mIU/mL at Week 4 following booster injection • to compare the immunogenicity of HEPLISAV with Engerix-B and Fendrix as measured by anti-HBs geometric mean concentration (GMC) at Weeks 4 and 12 following booster injection ;Primary end point(s): Seroprotection rate, defined as the percentage of subjects with anti-HBsAg serum concentration = 10 mIU/mL, measured at Week 4;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • incidence of post-injection reactions • incidence of AEs through Week 4 • incidence of SAEs and AESIs (autoimmune diseases) through Week 12 • SPR measured at Week 12 • portion of subjects with anti-HBs concentration = 100 mIU/mL at Week 4 • serum anti-HBs geometric mean concentration at Weeks 4 and 12;Timepoint(s) of evaluation of this end point: Post-injection reactions will be evaluated for 7 days following the administration of study injection on Day 1 For all other secondary end points, the timepoint of evaluation is given in E.5.2 | — |
Countries
Germany
Contacts
Public ContactReferat Klinische Prüfung
Paul-Ehrlich-Institut (PEI)
Outcome results
None listed