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

Ebola Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575456
• Other study ID #: JSVCT024
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2015
• Last updated: August 30, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pharmacy Board: Sierra Leone
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ebola Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Biological:
• Ebola Vaccine

• Placebo
control

Locations

Country	Name	City	State
Sierra Leone	Dr. Alie H Wurie	Freetown

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited adverse reactions after vaccination		7 days after vaccination	Yes
Primary	ELISA antigen-specific assays for antibody to GP responses		14 days after vaccination	No
Primary	ELISA antigen-specific assays for antibody to GP responses		28 days after vaccination	No
Primary	ELISA antigen-specific assays for antibody to GP responses		168 days after vaccination	No
Secondary	Occurrence of unsolicited adverse reactions after vaccination		28 days after vaccination	Yes
Secondary	Occurrence of serious adverse reaction during the whole follow-up period		6 months	Yes
Secondary	Post-vaccination Rate of infected with HIV		6 months	Yes
Secondary	Neutralizing antibody titers response to human Ad5		14 days after vaccination	No
Secondary	Neutralizing antibody titers response to human Ad5		28 days after vaccination	No
Secondary	Neutralizing antibody titers response to human Ad5		168 days after vaccination	No