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

Jiangsu Province Centers for Disease Control and Prevention1 site in 1 country500 target enrollmentOctober 2015

ConditionsEbola Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ebola Disease
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Enrollment: 500
Locations: 1
Primary Endpoint: Occurrence of solicited adverse reactions after vaccination
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Occurrence of solicited adverse reactions after vaccination

Time Frame: 7 days after vaccination

ELISA antigen-specific assays for antibody to GP responses

Time Frame: 168 days after vaccination

Secondary Outcomes

Occurrence of serious adverse reaction during the whole follow-up period(6 months)
Neutralizing antibody titers response to human Ad5(168 days after vaccination)
Occurrence of unsolicited adverse reactions after vaccination(28 days after vaccination)
Post-vaccination Rate of infected with HIV(6 months)