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

Primary Purpose

Ebola Disease

Status
Completed
Phase
Phase 2
Locations
Sierra Leone
Study Type
Interventional
Intervention
Ebola Vaccine
Placebo
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Disease

Eligibility Criteria

8 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Alie H Wurie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group C

Arm Description

(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

(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

(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

Outcomes

Primary Outcome Measures

Occurrence of solicited adverse reactions after vaccination
ELISA antigen-specific assays for antibody to GP responses
ELISA antigen-specific assays for antibody to GP responses
ELISA antigen-specific assays for antibody to GP responses

Secondary Outcome Measures

Occurrence of unsolicited adverse reactions after vaccination
Occurrence of serious adverse reaction during the whole follow-up period
Post-vaccination Rate of infected with HIV
Neutralizing antibody titers response to human Ad5
Neutralizing antibody titers response to human Ad5
Neutralizing antibody titers response to human Ad5

Full Information

First Posted
October 11, 2015
Last Updated
August 30, 2016
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02575456
Brief Title
A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
(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
Arm Title
Group B
Arm Type
Experimental
Arm Description
(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
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
(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
Intervention Type
Biological
Intervention Name(s)
Ebola Vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
control
Primary Outcome Measure Information:
Title
Occurrence of solicited adverse reactions after vaccination
Time Frame
7 days after vaccination
Title
ELISA antigen-specific assays for antibody to GP responses
Time Frame
14 days after vaccination
Title
ELISA antigen-specific assays for antibody to GP responses
Time Frame
28 days after vaccination
Title
ELISA antigen-specific assays for antibody to GP responses
Time Frame
168 days after vaccination
Secondary Outcome Measure Information:
Title
Occurrence of unsolicited adverse reactions after vaccination
Time Frame
28 days after vaccination
Title
Occurrence of serious adverse reaction during the whole follow-up period
Time Frame
6 months
Title
Post-vaccination Rate of infected with HIV
Time Frame
6 months
Title
Neutralizing antibody titers response to human Ad5
Time Frame
14 days after vaccination
Title
Neutralizing antibody titers response to human Ad5
Time Frame
28 days after vaccination
Title
Neutralizing antibody titers response to human Ad5
Time Frame
168 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alie H Wurie
Organizational Affiliation
Ministry of Health & Sanitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Alie H Wurie
City
Freetown
Country
Sierra Leone

12. IPD Sharing Statement

Learn more about this trial

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

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