A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.
A Phase 1 Double-blind, Dose-escalation, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults in China
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ad5-ebov ...
  • Study Participants

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.
Study Started
Dec 31
Primary Completion
Feb 28
Study Completion
Jul 31
Last Update
Aug 28

Biological Low dose Ebola Zaire vaccine (Ad5-EBOV)

one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)

Biological 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.

Biological placebo (one dose)

placebo, one doses

Biological placebo (two doses)

placebo, two doses, with one dose to each arm at a same time.

Placebo group (one shot) Placebo Comparator

one dose

Placebo group (two shots) Placebo Comparator

two doses, with one dose to each arm at a same time.

Low dose vaccine group Experimental

one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)

High dose vaccine group Experimental

two doses, high dose, with one dose to each arm at a same time


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
No Results Posted