Ebola Virus Disease Clinical Trial
Official title:
A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China
This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.
Status | Completed |
Enrollment | 61 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Aged between 18 and 60 years. - African in China. - 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 1 month). - A body mass index (BMI) 18.5-35.0 kg/m2 - Hemoglobin =110g/L for female, and =120g/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 - Active partial thromboplastin time (APTT) 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: - Family history of seizure, epilepsy, brain or mental disease - Participant 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, such as mannitol. - Woman who is pregnant, breast-feeding or positive in ß-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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | First affiliated hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University | Beijing Institute of Bioengineering, Academy of Military Medical Sciences, Tianjin Cansino Biotechnology Inc |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China. | From March to July, 2015 | Yes |
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