A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.
NCT ID: NCT02326194
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2014-12-31
2015-07-31
Brief Summary
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This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo group (one shot)
one dose
placebo (one dose)
placebo, one doses
Placebo group (two shots)
two doses, with one dose to each arm at a same time.
placebo (two doses)
placebo, two doses, with one dose to each arm at a same time.
Low dose vaccine group
one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)
Low dose Ebola Zaire vaccine (Ad5-EBOV)
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
High dose vaccine group
two doses, high dose, with one dose to each arm at a same time
High dose Ebola Zaire vaccine (Ad5-EBOV)
two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
Interventions
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Low dose Ebola Zaire vaccine (Ad5-EBOV)
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
High dose Ebola Zaire vaccine (Ad5-EBOV)
two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
placebo (one dose)
placebo, one doses
placebo (two doses)
placebo, two doses, with one dose to each arm at a same time.
Eligibility Criteria
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Inclusion Criteria
* Able to understand the content of informed consent and willing to sign the informed consent
* Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
* A body mass index (BMI) \<35
* Hemoglobin 110-150g/L for female, and 120-160g/L for male.
* White blood cells (WBC) 4.0-10.0×109 cells/L
* Total lymphocyte Count 0.8-4.5×109 cells/L
* Platelets 100-300×109 cells/L
* Alanine aminotransferase (ALT) 0-40U/L
* Serum creatinine 44-106μmol/L
* Partial thromboplastin time (PTT) 20-40 seconds
* Prothrombin time (PT) 10-14 seconds
* Negative in HIV diagnostic blood test
* Axillary temperature ≤37.0°C on the day of enrollment
* General good health as established by medical history and physical examination.
Exclusion Criteria
* Subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV vaccine, such as mannitol
* Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
* Any acute fever disease or infections in last 7 days
* Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
* Hereditary angioneurotic edema or acquired angioneurotic edema
* Urticaria in last one year
* Asplenia or functional asplenia
* Platelet disorder or other bleeding disorder may cause injection contraindication
* Faint at the sight of blood or needles.
* Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
* Prior administration of blood products in last 4 months
* Prior administration of other research medicines in last 1 month
* Prior administration of attenuated vaccine in last 1 month
* Prior administration of inactivated vaccine in last 14 days
* Current anti-tuberculosis prophylaxis or therapy
* Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
18 Years
60 Years
ALL
No
Sponsors
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Beijing Institute of Biotechnology
OTHER
Tianjin Cansino Biotechnology Inc
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Fengcai Zhu
Jiangsu Province Centers for Disease Control and Prevention
Locations
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Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
Taizhou, Jiangsu, China
Countries
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References
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Li JX, Hou LH, Meng FY, Wu SP, Hu YM, Liang Q, Chu K, Zhang Z, Xu JJ, Tang R, Wang WJ, Liu P, Hu JL, Luo L, Jiang R, Zhu FC, Chen W. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Glob Health. 2017 Mar;5(3):e324-e334. doi: 10.1016/S2214-109X(16)30367-9. Epub 2016 Dec 23.
Zhu FC, Hou LH, Li JX, Wu SP, Liu P, Zhang GR, Hu YM, Meng FY, Xu JJ, Tang R, Zhang JL, Wang WJ, Duan L, Chu K, Liang Q, Hu JL, Luo L, Zhu T, Wang JZ, Chen W. Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet. 2015 Jun 6;385(9984):2272-9. doi: 10.1016/S0140-6736(15)60553-0. Epub 2015 Mar 25.
Other Identifiers
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JSVCT020
Identifier Type: -
Identifier Source: org_study_id
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