Trial | NCT02575456  Report issue

Title

A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    500
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
Study Started
Oct 31
2015
Primary Completion
Jun 30
2016
Study Completion
Jul 31
2016
Last Update
Sep 01
2016
Estimate

Biological Ebola Vaccine

Biological Placebo

control

Group A Experimental

(4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection

Group B Experimental

(4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection

Group C Placebo Comparator

(0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection

Criteria 

Inclusion Criteria:

Aged between 18 and 50 years
Able to understand the content of informed consent and signed the informed consent
Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
Negative in HIV diagnostic blood test on day of enrollment
Axillary temperature ≤37.0°C on the day of enrollment
Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
General good health as established by medical history and physical examination.

Exclusion Criteria:

Infected by Ebola virus (inquiry)
Vaccination with other Ebola vaccine (inquiry)
HIV infection or other serious immunodeficiency disease (inquiry)
Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
Family history of brain or mental disease
Woman who is pregnant or breast-feeding
Any acute fever disease or infections in last 7 days
Major congenital defects or not well-controlled chronic illness
Asplenia or functional asplenia
Platelet disorder or other bleeding disorder
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 other research medicines in last 1 month
Prior administration of attenuated vaccine(s) in the last one month
Prior administration of inactivated vaccine(s) in the last 14 days
Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
No Results Posted