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

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 Overview

• Status: Completed
• Conditions: Ebola Disease
• Intervention / Treatment: Biological: Ebola Vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sierra Leone
  • Freetown, Sierra Leone
    • Dr. Alie H Wurie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; (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
Experimental: Group B; (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
Placebo Comparator: Group C; (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; control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborators: Beijing Institute of Biotechnology; Tianjin Cansino Biotechnology Inc
• Investigators: Principal Investigator: Alie H Wurie, Ministry of Health & Sanitation

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Mononegavirales Infections; Hemorrhagic Fevers, Viral; Filoviridae Infections; Virus Diseases; Hemorrhagic Fever, Ebola
• Other Study ID Numbers: JSVCT024