Trial record 1 of 1 for:
PROTECT Sci-B-Vac
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
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| ClinicalTrials.gov Identifier: NCT03393754 |
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Recruitment Status :
Completed
First Posted : January 8, 2018
Results First Posted : July 7, 2020
Last Update Posted : July 17, 2020
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Sponsor:
VBI Vaccines Inc.
Information provided by (Responsible Party):
VBI Vaccines Inc.
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Brief Summary:
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B Vaccines | Biological: Hepatitis B Vaccination | Phase 3 |
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1607 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 3 Double-Blind Randomized Controlled Trial 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 (PROTECT) |
| Actual Study Start Date : | December 13, 2017 |
| Actual Primary Completion Date : | April 8, 2019 |
| Actual Study Completion Date : | April 8, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sci-B-Vac® Hepatitis B Vaccination
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
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Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination |
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Active Comparator: Engerix-B® Hepatitis B Vaccination
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
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Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination |
Primary Outcome Measures :
- Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 [ Time Frame: Day 196 ]To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; 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%.
- Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 [ Time Frame: Day 196 ]To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided 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 receiving the third vaccination, will be > 5%.
Secondary Outcome Measures :
- Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Day of vaccine administration and six subsequent days ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Any gender.
- Age ≥ 18 years
- 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, Chronic Obstructive Pulmonary Disease (COPD) and 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
- If female, either is not of childbearing potential 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
- Able and willing to give consent.
Exclusion Criteria:
- Previous vaccination with any Hep B vaccine (licensed or experimental).
- 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).
- Known 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 weeks 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 (Engerix-B® or Sci-B-Vac®)
- Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method
- Immediate family members of study center staff (parents, sibling, children)
- Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers at screening
- 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 at screening
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Any laboratory test abnormality that would be considered of Grade 1 severity and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
- Diagnosis of advanced stage heart failure or Unstable Angina.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393754
Locations
Show 28 study locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
| Study Director: | Francisco Diaz-Mitoma, MD, PhD | VBI Vaccines |
Study Documents (Full-Text)
Documents provided by VBI Vaccines Inc.:
Documents provided by VBI Vaccines Inc.:
Study Protocol [PDF] July 17, 2017
Statistical Analysis Plan [PDF] May 13, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VBI Vaccines Inc. |
| ClinicalTrials.gov Identifier: | NCT03393754 |
| Other Study ID Numbers: |
Sci-B-Vac-001 2017-001819-36 ( EudraCT Number ) |
| First Posted: | January 8, 2018 Key Record Dates |
| Results First Posted: | July 7, 2020 |
| Last Update Posted: | July 17, 2020 |
| Last Verified: | July 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by VBI Vaccines Inc.:
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Hepatitis B Vaccines |
Additional relevant MeSH terms:
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Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |