A trial to compare the immune response and safety of 3 doses of Sci-B-Vac™ compared to 3 doses of Engerix-B® in Adults.

Phase 1

• Conditions: Hepatitis B vaccination in healthy adults; MedDRA version: 20.0Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-001819-36-BE
• Lead Sponsor: VBI Vaccines Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1564

Inclusion Criteria

Subjects must meet all the following criteria to be eligible:
1. Any gender.
2. Age = 18 years.
3. In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, COPD, asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index =3 17(see Appendix 1 of the protocol).
4. If female:
either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
OR
is of childbearing potential and must agree to use an adequate birth control method during the screening period 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 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 938
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 626

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded:

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 a prednisolone-equivalent dose >20 mg /day (Inhaled and topical steroids are allowed.
3.Known 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);
OR
b)secondary immunodeficiency disorders (e.g. resulting from HIV/AIDS (Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection), solid organ transplant, splenectomy);
OR
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 week prior to enrollment.
7.Has received blood products or immunoglobulin within 90 days of enrollment 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 colony 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 a 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 (Engerix-B® or Sci-B-Vac™).
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.Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers (anti-HBc, anti-HBs, HBsAg) at screening.
16.Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured (defined as documented sustained virologic response (SVR) or negative viral load = 12 weeks after cessation of

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified