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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02326194
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : August 28, 2015
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Information provided by (Responsible Party):
Fengcai Zhu, 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.


Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: Low dose Ebola Zaire vaccine (Ad5-EBOV) Biological: High dose Ebola Zaire vaccine (Ad5-EBOV) Biological: placebo (one dose) Biological: placebo (two doses) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Placebo Comparator: Placebo group (one shot)
one dose
Biological: placebo (one dose)
placebo, one doses

Placebo Comparator: Placebo group (two shots)
two doses, with one dose to each arm at a same time.
Biological: placebo (two doses)
placebo, two doses, with one dose to each arm at a same time.

Experimental: Low dose vaccine group
one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)
Biological: Low dose Ebola Zaire vaccine (Ad5-EBOV)
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)

Experimental: High dose vaccine group
two doses, high dose, with one dose to each arm at a same time
Biological: 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.




Primary Outcome Measures :
  1. Occurrence of adverse reactions after vaccination. [ Time Frame: within 7 days after the vaccination ]
    Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).

  2. Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 28 days after the vaccination ]
    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA.

  3. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 28 days after the vaccination ]
    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)


Secondary Outcome Measures :
  1. Occurrence of adverse events after the vaccination. [ Time Frame: within 28 days after the vaccination ]
    Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).

  2. Changes of the laboratory examinations after vaccination. [ Time Frame: day 0-28 after the vaccination ]
    Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.

  3. Occurrence of serious adverse events after the vaccination. [ Time Frame: within 6 months after the vaccination ]
    Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).

  4. Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.

  5. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).

  6. Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
    Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.


Other Outcome Measures:
  1. Changes of the laboratory examinations after vaccination. [ Time Frame: day 168 after the vaccination ]
    Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) at day 168.

  2. Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 3-112 days after the vaccination ]
    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. Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 3-56 days after the vaccination ]
    Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112.

  4. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: day 7-112 after the vaccination ]
    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).

  5. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: day 0-168 after the vaccination ]
    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 0, 28 and 168 as measured by ELISpot.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326194


Locations
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China, Jiangsu
Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
Taizhou, Jiangsu, China
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02326194    
Other Study ID Numbers: JSVCT020
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention:
Safety,immunogenicity,Ebola
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs