A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 3200

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) 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 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 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

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.
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 hepa

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

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