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



Status:Active, not recruiting
Conditions:Vaccines, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 45
Updated:11/23/2018
Start Date:December 14, 2017
End Date:October 22, 2019

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

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

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.

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.
We found this trial at
16
sites
5901 West Olympic Boulevard
Los Angeles, California 90036
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Phone: 386-740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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2128 W Flagler St # 201
Miami, Florida 33144
Phone: 305-631-6704
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Miami, FL
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Phone: 714-774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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175 Country Club Drive
Atlanta, Georgia 30281
Phone: 770-507-6867
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Atlanta, GA
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675 Peachwood Drive
Birmingham, Alabama 35216
Phone: 205-757-8212
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Boise, Idaho 83642
Phone: 208-377-8653
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Cleveland, Ohio 44122
Phone: 216-682-0320
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Columbus, Ohio 43213
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10 Corneel Heymanslaan
Gent, Oost-Vlaanderen 9000
Phone: +329-332-3328
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Gent,
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Las Vegas, Nevada 89104
Phone: 702-893-8968
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Missoula, Montana
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North Hollywood, California 91606
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Phone: 405-602-3927
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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3590 West 9000 South
Salt Lake City, Utah 84088
Phone: 801-542-8190
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Tempe, AZ
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