Clinical study to compare the safety and immune response of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis who were previously vaccinated without success.
- Conditions
- Prevention of hepatitis B virus (HBV) infectionMedDRA version: 14.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-019633-10-DE
- Lead Sponsor
- Dynavax Technologies Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
• 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 < 10 mIU/mL)
a) after responding (had anti-HBs = 10 mIU/mL) to one series of hepatitis B vaccine, with or without booster(s), or
b) after failing to respond (had anti-HBs < 10 mIU/mL) to at least one series of hepatitis B vaccine and one or more booster(s) of hepatitis B vaccine
• in the opinion of the investigator, is clinically stable and without clinically significant abnormal laboratory results in the setting of hemodialysis
• be serum negative for HBsAg, anti-HBc, hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
• if female, and of childbearing potential*, subject must be:
• Surgically sterile (hysterectomy or bilateral tubal ligation) or
• Neither pregnant nor breast-feeding, consistently using a highly effective method of birth control(1) for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study
*defined as not at least 1 year postmenopausal
(1)Highly effective methods of birth control (with a documented failure rate of less than 1% per year) include oral or systemic contraceptives, total abstinence, sterilization of male partner and hormone releasing IUDs.
• is not scheduled to undergo a kidney transplant in the next 3 months
• 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
• 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
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