Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Study Overview
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Brief Summary
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A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Detailed Description
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The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.

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

Conditions
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Hepatitis B Vaccines

Intervention / Treatment
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* Biological: Hepatitis B Vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender Age 18-45 years Healthy, as determined by a physical examination and values of laboratory tests If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method Able and willing to give informed consent Exclusion Criteria: Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental) Treatment by immunosuppressant within 30 days of enrollment History of immunological function impairment Pregnancy or breastfeeding Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment History of allergic reactions or anaphylactic reaction to any vaccine component Unwilling, or unable in the opinion of the investigator, to comply with study requirements Immediate family members of study center staff Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening Renal impairment with Glomerular Filtration Rate (GFR) <90 mL/min/ 1.73 m2 at screening BMI ≥ 35 Uncontrolled hypertension Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sci-B-Vac Lot A Hep B Vaccination<br>Sci-B-Vac Lot A Hepatitis B Vaccination | Biological: Hepatitis B Vaccination<br>* Hepatitis B Vaccination<br>|
| Experimental: Sci-B-Vac Lot B Hep B Vaccination<br>Sci-B-Vac Lot B Hepatitis B Vaccination | Biological: Hepatitis B Vaccination<br>* Hepatitis B Vaccination<br>|
| Experimental: Sci-B-Vac Lot C Hep B Vaccination<br>Sci-B-Vac Lot C Hepatitis B Vaccination | Biological: Hepatitis B Vaccination<br>* Hepatitis B Vaccination<br>|
| Active Comparator: Comparator: ENGERIX-B Hep B Vaccination<br>Active Comparator: ENGERIX-B Hepatitis B Vaccination | Biological: Hepatitis B Vaccination<br>* Hepatitis B Vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of [0.67, 1.5]. | 4 weeks after third vaccination (Study Day 196) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) | The difference in proportions [SPR(Sci-B-Vac®)-SPR(Engerix-B®)] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was > 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B® | 4 weeks after third vaccination (Study Day 196) | 
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Analysis of local and systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old. | Day of vaccine administration and six subsequent days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Vaccines