A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Ebola Disease

Intervention / Treatment
-----------------
* Biological: Ebola Vaccine
* Biological: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>(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 | Biological: Ebola Vaccine<br> <br> |
| Experimental: Group B<br>(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 | Biological: Ebola Vaccine<br> <br> |
| Placebo Comparator: Group C<br>(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 | Biological: Placebo<br>* control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited adverse reactions after vaccination |  | 7 days after vaccination | 
| ELISA antigen-specific assays for antibody to GP responses |  | 14 days after vaccination | 
| ELISA antigen-specific assays for antibody to GP responses |  | 28 days after vaccination | 
| ELISA antigen-specific assays for antibody to GP responses |  | 168 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unsolicited adverse reactions after vaccination |  | 28 days after vaccination | 
| Occurrence of serious adverse reaction during the whole follow-up period |  | 6 months | 
| Post-vaccination Rate of infected with HIV |  | 6 months | 
| Neutralizing antibody titers response to human Ad5 |  | 14 days after vaccination | 
| Neutralizing antibody titers response to human Ad5 |  | 28 days after vaccination | 
| Neutralizing antibody titers response to human Ad5 |  | 168 days after vaccination |