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

NCT ID: NCT02575456

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-07-31

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.

Conditions

Ebola Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Ebola Vaccine

Intervention Type: BIOLOGICAL

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

Group Type: EXPERIMENTAL

Ebola Vaccine

Intervention Type: BIOLOGICAL

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

control

Interventions

Ebola Vaccine

Intervention Type: BIOLOGICAL

Placebo

control

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Institute of Biotechnology

OTHER

Sponsor Role: collaborator

Tianjin Cansino Biotechnology Inc

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alie H Wurie

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health & Sanitation

Locations

Dr. Alie H Wurie

Freetown, , Sierra Leone

Countries

Sierra Leone

Other Identifiers

JSVCT024

Identifier Type: -

Identifier Source: org_study_id