Ebola Virus Disease
Conditions
Keywords
Vaccines, Ebola Virus Disease
Brief summary
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.
Detailed description
This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV. The whole follow-up period for each participant will be 28 days.
Interventions
BIOLOGICALAd5-EBOV
intramuscular injection
Sponsors
Beijing Institute of Bioengineering, Academy of Military Medical Sciences
Tianjin Cansino Biotechnology Inc
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed