A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

Ebola Virus Disease Clinical Trial

Official title:

A Phase 1 Double-blind, Dose-escalation, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326194
• Other study ID #: JSVCT020
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2014
• Last updated: August 27, 2015
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃.

This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 60 years.

• Able to understand the content of informed consent and willing to sign the informed consent

• Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).

• A body mass index (BMI) <35

• Hemoglobin 110-150g/L for female, and 120-160g/L for male.

• White blood cells (WBC) 4.0-10.0×109 cells/L

• Total lymphocyte Count 0.8-4.5×109 cells/L

• Platelets 100-300×109 cells/L

• Alanine aminotransferase (ALT) 0-40U/L

• Serum creatinine 44-106µmol/L

• Partial thromboplastin time (PTT) 20-40 seconds

• Prothrombin time (PT) 10-14 seconds

• Negative in HIV diagnostic blood test

• Axillary temperature =37.0°C on the day of enrollment

• General good health as established by medical history and physical examination.

Exclusion Criteria:

• Family history of seizure, epilepsy, brain or mental disease

• Subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV vaccine, such as mannitol

• Woman who is pregnant, breast-feeding or positive in ß-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months

• Any acute fever disease or infections in last 7 days

• Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease

• Hereditary angioneurotic edema or acquired angioneurotic edema

• Urticaria in last one year

• Asplenia or functional asplenia

• Platelet disorder or other bleeding disorder may cause injection contraindication

• 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 blood products in last 4 months

• Prior administration of other research medicines in last 1 month

• Prior administration of attenuated vaccine in last 1 month

• Prior administration of inactivated vaccine in last 14 days

• Current anti-tuberculosis prophylaxis or therapy

• Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Study Design

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

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Biological:
• Low dose Ebola Zaire vaccine (Ad5-EBOV)
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
• High dose Ebola Zaire vaccine (Ad5-EBOV)
two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
• placebo (one dose)
placebo, one doses
• placebo (two doses)
placebo, two doses, with one dose to each arm at a same time.

Locations

Country	Name	City	State
China	Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention	Taizhou	Jiangsu

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

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of the laboratory examinations after vaccination.	Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) at day 168.	day 168 after the vaccination	Yes
Other	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112 as measured by ELISA.	3-112 days after the vaccination	No
Other	Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).	Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112.	3-56 days after the vaccination	No
Other	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 7, 14, 56 and 112 as measured by intracellular cytokine staining assays (ICS).	day 7-112 after the vaccination	No
Other	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 0, 28 and 168 as measured by ELISpot.	day 0-168 after the vaccination	No
Primary	Occurrence of adverse reactions after vaccination.	Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).	within 7 days after the vaccination	Yes
Primary	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA.	28 days after the vaccination	No
Primary	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)	28 days after the vaccination	No
Secondary	Occurrence of adverse events after the vaccination.	Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).	within 28 days after the vaccination	Yes
Secondary	Changes of the laboratory examinations after vaccination.	Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.	day 0-28 after the vaccination	Yes
Secondary	Occurrence of serious adverse events after the vaccination.	Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).	within 6 months after the vaccination	Yes
Secondary	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.	168 days after the vaccination	No
Secondary	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).	Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).	168 days after the vaccination	No
Secondary	Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).	Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.	168 days after the vaccination	No