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A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

Primary Purpose

Ebola Virus Disease

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Ad5-EBOV

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Aged between 18 and 60 years.
African in China.
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 1 month).
A body mass index (BMI) 18.5-35.0 kg/m2
Hemoglobin ≥110g/L for female, and ≥120g/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
Active partial thromboplastin time (APTT) 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
Participant 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, 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

First affiliated hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

low dose

High dose

Arm Description

30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Outcomes

Primary Outcome Measures

A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.

Secondary Outcome Measures

Full Information

NCT ID

NCT02401373

First Posted

March 24, 2015

Last Updated

July 15, 2015

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Beijing Institute of Bioengineering, Academy of Military Medical Sciences, Tianjin Cansino Biotechnology Inc

1. Study Identification

Unique Protocol Identification Number

NCT02401373

Brief Title

A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

Official Title

A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Beijing Institute of Bioengineering, Academy of Military Medical Sciences, Tianjin Cansino Biotechnology Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.

Detailed Description

This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV. The whole follow-up period for each participant will be 28 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ebola Virus Disease

Keywords

Vaccines, Ebola Virus Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low dose

Arm Type

Experimental

Arm Description

30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Arm Title

High dose

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Ad5-EBOV

Intervention Description

intramuscular injection

Primary Outcome Measure Information:

Title

A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.

Time Frame

From March to July, 2015

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged between 18 and 60 years. African in China. 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 1 month). A body mass index (BMI) 18.5-35.0 kg/m2 Hemoglobin ≥110g/L for female, and ≥120g/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 Active partial thromboplastin time (APTT) 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 Participant 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, 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lanjuan Li

Organizational Affiliation

First Affiliated Hospital of Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

28708962

Citation

Wu L, Zhang Z, Gao H, Li Y, Hou L, Yao H, Wu S, Liu J, Wang L, Zhai Y, Ou H, Lin M, Wu X, Liu J, Lang G, Xin Q, Wu G, Luo L, Liu P, Shentu J, Wu N, Sheng J, Qiu Y, Chen W, Li L. Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother. 2017 Sep 2;13(9):2078-2085. doi: 10.1080/21645515.2017.1342021. Epub 2017 Jul 14.

Results Reference

derived

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A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

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