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
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Tempe, AZ
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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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DeLand, FL
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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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Anaheim, CA
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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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Birmingham, AL
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Boise, Idaho 83642
Phone: 208-377-8653
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Boise, ID
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Cleveland, Ohio 44122
Phone: 216-682-0320
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Cleveland, OH
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Columbus, Ohio 43213
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Columbus, OH
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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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Las Vegas, NV
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5901 West Olympic Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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Missoula, Montana
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Missoula, MT
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North Hollywood, California 91606
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North Hollywood, CA
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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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Oklahoma City, OK
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3590 West 9000 South
Salt Lake City, Utah 84088
Phone: 801-542-8190
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Salt Lake City, UT
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