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

Primary Purpose

Ebola Virus Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low dose Ebola Zaire vaccine (Ad5-EBOV)
High dose Ebola Zaire vaccine (Ad5-EBOV)
placebo (one dose)
placebo (two doses)
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Virus Disease focused on measuring Safety,immunogenicity,Ebola

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo group (one shot)

Placebo group (two shots)

Low dose vaccine group

High dose vaccine group

Arm Description

one dose

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

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

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

Outcomes

Primary Outcome Measures

Occurrence of adverse reactions after vaccination.
Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
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.
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)

Secondary Outcome Measures

Occurrence of adverse events after the vaccination.
Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
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.
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).
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.
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).
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.

Full Information

First Posted
December 22, 2014
Last Updated
August 27, 2015
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02326194
Brief Title
A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease
Keywords
Safety,immunogenicity,Ebola

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group (one shot)
Arm Type
Placebo Comparator
Arm Description
one dose
Arm Title
Placebo group (two shots)
Arm Type
Placebo Comparator
Arm Description
two doses, with one dose to each arm at a same time.
Arm Title
Low dose vaccine group
Arm Type
Experimental
Arm Description
one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)
Arm Title
High dose vaccine group
Arm Type
Experimental
Arm Description
two doses, high dose, with one dose to each arm at a same time
Intervention Type
Biological
Intervention Name(s)
Low dose Ebola Zaire vaccine (Ad5-EBOV)
Intervention Description
one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
Intervention Type
Biological
Intervention Name(s)
High dose Ebola Zaire vaccine (Ad5-EBOV)
Intervention Description
two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
Intervention Type
Biological
Intervention Name(s)
placebo (one dose)
Intervention Description
placebo, one doses
Intervention Type
Biological
Intervention Name(s)
placebo (two doses)
Intervention Description
placebo, two doses, with one dose to each arm at a same time.
Primary Outcome Measure Information:
Title
Occurrence of adverse reactions after vaccination.
Description
Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time Frame
within 7 days after the vaccination
Title
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA.
Time Frame
28 days after the vaccination
Title
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)
Time Frame
28 days after the vaccination
Secondary Outcome Measure Information:
Title
Occurrence of adverse events after the vaccination.
Description
Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time Frame
within 28 days after the vaccination
Title
Changes of the laboratory examinations after vaccination.
Description
Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.
Time Frame
day 0-28 after the vaccination
Title
Occurrence of serious adverse events after the vaccination.
Description
Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time Frame
within 6 months after the vaccination
Title
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.
Time Frame
168 days after the vaccination
Title
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).
Time Frame
168 days after the vaccination
Title
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.
Time Frame
168 days after the vaccination
Other Pre-specified Outcome Measures:
Title
Changes of the laboratory examinations after vaccination.
Description
Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) at day 168.
Time Frame
day 168 after the vaccination
Title
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112 as measured by ELISA.
Time Frame
3-112 days after the vaccination
Title
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112.
Time Frame
3-56 days after the vaccination
Title
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
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).
Time Frame
day 7-112 after the vaccination
Title
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Description
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 0, 28 and 168 as measured by ELISpot.
Time Frame
day 0-168 after the vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
City
Taizhou
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28017642
Citation
Li JX, Hou LH, Meng FY, Wu SP, Hu YM, Liang Q, Chu K, Zhang Z, Xu JJ, Tang R, Wang WJ, Liu P, Hu JL, Luo L, Jiang R, Zhu FC, Chen W. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Glob Health. 2017 Mar;5(3):e324-e334. doi: 10.1016/S2214-109X(16)30367-9. Epub 2016 Dec 23.
Results Reference
derived
PubMed Identifier
25817373
Citation
Zhu FC, Hou LH, Li JX, Wu SP, Liu P, Zhang GR, Hu YM, Meng FY, Xu JJ, Tang R, Zhang JL, Wang WJ, Duan L, Chu K, Liang Q, Hu JL, Luo L, Zhu T, Wang JZ, Chen W. Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet. 2015 Jun 6;385(9984):2272-9. doi: 10.1016/S0140-6736(15)60553-0. Epub 2015 Mar 25.
Results Reference
derived

Learn more about this trial

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

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