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

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: NCT02401373
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborators:
Beijing Institute of Bioengineering, Academy of Military Medical Sciences
Tianjin Cansino Biotechnology Inc
Information provided by (Responsible Party):
Lanjuan Li, First Affiliated Hospital of Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: Ad5-EBOV Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: low dose
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).
Biological: Ad5-EBOV
intramuscular injection

Experimental: High dose
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).
Biological: Ad5-EBOV
intramuscular injection




Primary Outcome Measures :
  1. 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 ]


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:   Yes
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

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): NCT02401373


Locations
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China, Zhejiang
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Beijing Institute of Bioengineering, Academy of Military Medical Sciences
Tianjin Cansino Biotechnology Inc
Investigators
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Principal Investigator: Lanjuan Li First Affiliated Hospital of Zhejiang University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lanjuan Li, Academy of Engineering, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT02401373    
Other Study ID Numbers: GR2015VCT001
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Keywords provided by Lanjuan Li, First Affiliated Hospital of Zhejiang University:
Vaccines
Ebola Virus Disease
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections