Hepatitis B Vaccination MedDRA version: 20.0 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 100000004865
Conditions
Sponsors
VBI Vaccines INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any gender. 2. Age 18-45 years. 3. Healthy, as determined by a physical examination and values of laboratory tests. 4. If female a) either not of childbearing potential, defined as postmenopausal (12 months with no menses without an alternative medical cause) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), OR b) is of childbearing potential and must agree to use an adequate birth control method 4 weeks prior to first vaccination and until the end of her participation in the study (effective birth control includes: 1) hormonal (implant, oral, vaginal, transdermal) contraceptives; 2) diaphragm with spermicide, condom (with or without spermicide); 3) intra-uterine devices; and 4) vasectomy of male partner; 5) abstinence from penile-vaginal intercourse (if the preferred and usual lifestyle of the subject)). 5. Able and willing to give 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 3200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous vaccination with any HBV vaccine (licensed or experimental). 2. Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or > 20 mg /day prednisolone equivalent (Inhaled and topical steroids are allowed). 3. History of immunological function impairment, including but not limited to: a) autoimmune diseases (e.g. multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis - including Hashimoto thyroiditis, Grave's or Basedow’s disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain-Barré syndrome, Addison’s Disease, Bell’s Palsy and Alopecia Areata); b) secondary immunodeficiency disorders (e.g. Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ transplant, splenectomy); c) primary immunodeficiency disorders (e.g. common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency). 4.Pregnancy or breastfeeding. 5. Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment. 6. Immunization with inactivated vaccines (e.g. influenza) within 2 weeks prior to enrolment. 7. Has received blood products or immunoglobulin within 90 days prior to study entry or likely to require blood products during the study period. 8. Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment. 9. Has received granulocyte-macrophage stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF erythropoietin during the study period. 10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. Subject with an history of low risk basal cell carcinoma will be accepted (low risk being defined by the following: 1) location on the trunk of the body, arms, legs, cheeks, forehead, temples, scalp, neck or chin and 2) less than 2 cm, and 3) nodular or superficial, and 4) primary cancer that has not come back after treatment and 5) edge of the cancerous area is clear and smooth and 6) not located in or around nerves). 11. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment. 12. History of allergic reactions or anaphylactic reaction to any vaccine component or allergy to latex. 13. Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method. 14. Immediate family members of study center staff (parents, sibling, children). 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Immunogenicity To demonstrate that the SPR 4 weeks after completion of the three-dose regiment of Sci-B-Vac™ is non-inferior to a three-dose regimen of EngerixB®, i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac™ arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination will be > -5. Safety To assess the safety and reactogenicity of Sci-B-Vac™ compared to EngerixB® Please refer to the protocol for the Exploratory objectives ; Primary end point(s): Immunogenicity endpoints Geometric Mean Concentration (GMC) of anti-HBs in serum after 2 vaccinations, just prior to receiving the third vaccination, and 4 weeks and 24 weeks after the third vaccination with Sci-B-Vac™ or Engerix-B®, on Study Days 168, 196, and 336, respectively. The GMC at Study Day 196 is the basis for assessing lot-to-lot consistency of the three consecutive lots of Sci-B-Vac™. • Seroprotection rate after 2 vaccinations, just prior to receiving the third vaccination, and 4 weeks and 24 weeks after the third vaccination with Sci-B-Vac™ or Engerix-B®, on Study Days 168, 196, and 336, respectively. Seroprotection is defined as anti-HBs levels = 10mIU/mL in serum. Seroprotection rate is the percentage (%) of subjects achieving seroprotection. • Proportion of subjects achieving anti-HBs levels = 100mIU/mL in serum after 2 vaccinations, just prior to receiving the third vaccination, and 4 weeks and 24 weeks after the third vaccination with Sci-BVac™ or Engerix-B® on Study Days 168, 196, and 336, respectively. • Rate of non-response on Study Day 196, 4 weeks after the third vaccination with Sci-B-Vac™ or Engerix-B®. Rate of non-response is defined as the proportion of subjects not attaining anti-HBs levels = 10mIU/mL in serum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium, Canada, Finland, Germany, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
VBI Vaccines INC.
Outcome results
None listed