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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 2

Conditions: Ebola Disease

Treatments: Biological: Placebo; Biological: Ebola Vaccine

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT02575456

JSVCT024

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 3 patient groups, including a placebo group

Group A

Experimental group

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

Treatment:

Biological: Ebola Vaccine

Group B

Experimental group

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

Treatment:

Biological: Ebola Vaccine

Group C

Placebo Comparator group

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

Treatment:

Biological: Placebo