Ebola Virus Disease
Conditions
Keywords
Safety,immunogenicity,Ebola
Brief summary
Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. 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.
Interventions
BIOLOGICALLow dose Ebola Zaire vaccine (Ad5-EBOV)
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
BIOLOGICALHigh 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.
BIOLOGICALplacebo (one dose)
placebo, one doses
BIOLOGICALplacebo (two doses)
placebo, two doses, with one dose to each arm at a same time.
Sponsors
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 60 years. * 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
* Family history of seizure, epilepsy, brain or mental disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse reactions after vaccination. | within 7 days after the vaccination | Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV). |
| Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). | 28 days after the vaccination | Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS) |
| Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). | 28 days after the vaccination | Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of serious adverse events after the vaccination. | within 6 months after the vaccination | Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV). |
| Occurrence of adverse events after the vaccination. | within 28 days after the vaccination | Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV). |
| Changes of the laboratory examinations after vaccination. | day 0-28 after the vaccination | Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28. |
| Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). | 168 days after the vaccination | Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA. |
| Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). | 168 days after the vaccination | Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS). |
| Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). | 168 days after the vaccination | Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). | 3-112 days after the vaccination | Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112 as measured by ELISA. |
| Changes of the laboratory examinations after vaccination. | day 168 after the vaccination | Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) at day 168. |
| Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). | day 7-112 after the vaccination | Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 7, 14, 56 and 112 as measured by intracellular cytokine staining assays (ICS). |
| Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). | 3-56 days after the vaccination | Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112. |
Countries
China
Outcome results
None listed