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

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

Sponsors

Lead Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Collaborator: Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc

Source Jiangsu Province Centers for Disease Control and Prevention
Brief 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.

Overall Status Completed
Start Date 2014-12-01
Completion Date 2015-07-01
Primary Completion Date 2015-02-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Occurrence of adverse reactions after vaccination. within 7 days after the vaccination
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). 28 days after the vaccination
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). 28 days after the vaccination
Secondary Outcome
Measure Time Frame
Occurrence of adverse events after the vaccination. within 28 days after the vaccination
Changes of the laboratory examinations after vaccination. day 0-28 after the vaccination
Occurrence of serious adverse events after the vaccination. within 6 months after the vaccination
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). 168 days after the vaccination
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). 168 days after the vaccination
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). 168 days after the vaccination
Enrollment 120
Condition
Intervention

Intervention Type: Biological

Intervention Name: Low dose Ebola Zaire vaccine (Ad5-EBOV)

Description: one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)

Arm Group Label: Low dose vaccine group

Intervention Type: Biological

Intervention Name: High dose Ebola Zaire vaccine (Ad5-EBOV)

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

Arm Group Label: High dose vaccine group

Intervention Type: Biological

Intervention Name: placebo (one dose)

Description: placebo, one doses

Arm Group Label: Placebo group (one shot)

Intervention Type: Biological

Intervention Name: placebo (two doses)

Description: placebo, two doses, with one dose to each arm at a same time.

Arm Group Label: Placebo group (two shots)

Eligibility

Criteria:

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 β-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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Location
Facility: Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
Location Countries

China

Verification Date

2015-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Jiangsu Province Centers for Disease Control and Prevention

Investigator Full Name: Fengcai Zhu

Investigator Title: Jiangsu Province Centers for Disease Control and Prevention

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Placebo group (one shot)

Type: Placebo Comparator

Description: one dose

Label: Placebo group (two shots)

Type: Placebo Comparator

Description: two doses, with one dose to each arm at a same time.

Label: Low dose vaccine group

Type: Experimental

Description: one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)

Label: High dose vaccine group

Type: Experimental

Description: two doses, high dose, with one dose to each arm at a same time

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

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