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A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization

Primary Purpose

Ebola Virus Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
placebo
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 vaccine, boosting

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who enrolled in the initial study, and completed the primary vaccination.
  • Able to understand the content of the additional informed consent and willing to sign the additional informed consent for the boosting study
  • Able and willing to complete a one-month follow-up.
  • HIV negative
  • Axillary temperature ≤37.0°C on the day of enrollment
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

New occurrence of any of the following situation after the primary vaccination:

  • 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 become pregnant after the primary vaccination or is positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment for the boosting study
  • Any acute fever disease or infections in last 7 days
  • Not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last 6 months
  • 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 Type

Experimental

Experimental

Placebo Comparator

Arm Label

low dose group

high dose group

placebo group

Arm Description

4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)

1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)

placebo

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)

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)
Occurrence of serious adverse events after the vaccination
Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)
Serum neutralizing antibody against the Ad5-vector
Serum neutralizing antibody against the Ad5-vector 28 days after the boosting

Full Information

First Posted
August 21, 2015
Last Updated
October 11, 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
NCT02533791
Brief Title
A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization
Official Title
Safety and Immunogenicity of a Booster Dose of the Recombinant Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults After Primary Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
No

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℃. In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. The investigators intent to evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study. The investigators expect that the boosting immunization with a same vaccine for primary immunization is possible and could confer a longer-lived protection when needed. The phase I trial has been unblind 28 days after the primary vaccination, but all the subjects are still kept blind as well as the laboratory staffs. Therefore, this booster vaccination trial will be conduct in single blind.

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 vaccine, boosting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose group
Arm Type
Experimental
Arm Description
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
Arm Title
high dose group
Arm Type
Experimental
Arm Description
1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Biological
Intervention Name(s)
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
Intervention Description
one dose, 4×10^10vp/1ml per dose
Intervention Type
Biological
Intervention Name(s)
1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
Intervention Description
two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
Intervention Type
Biological
Intervention Name(s)
placebo
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 boosting
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 boosting
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)
Time Frame
28 days after the boosting
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 boosting
Title
Occurrence of serious adverse events after the vaccination
Description
Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)
Time Frame
within 28 days after the boosting
Title
Serum neutralizing antibody against the Ad5-vector
Description
Serum neutralizing antibody against the Ad5-vector 28 days after the boosting
Time Frame
28 days after the boosting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who enrolled in the initial study, and completed the primary vaccination. Able to understand the content of the additional informed consent and willing to sign the additional informed consent for the boosting study Able and willing to complete a one-month follow-up. HIV negative Axillary temperature ≤37.0°C on the day of enrollment General good health as established by medical history and physical examination. Exclusion Criteria: New occurrence of any of the following situation after the primary vaccination: 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 become pregnant after the primary vaccination or is positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment for the boosting study Any acute fever disease or infections in last 7 days Not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last 6 months 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Cai Zhu
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
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

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A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization

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