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A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine

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: NCT02575456
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : September 1, 2016
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Brief Summary:
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.

Condition or disease Intervention/treatment Phase
Ebola Disease Biological: Ebola Vaccine Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Group A
(4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
Biological: Ebola Vaccine
Experimental: Group B
(4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
Biological: Ebola Vaccine
Placebo Comparator: Group C
(0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
Biological: Placebo
control




Primary Outcome Measures :
  1. Occurrence of solicited adverse reactions after vaccination [ Time Frame: 7 days after vaccination ]
  2. ELISA antigen-specific assays for antibody to GP responses [ Time Frame: 14 days after vaccination ]
  3. ELISA antigen-specific assays for antibody to GP responses [ Time Frame: 28 days after vaccination ]
  4. ELISA antigen-specific assays for antibody to GP responses [ Time Frame: 168 days after vaccination ]

Secondary Outcome Measures :
  1. Occurrence of unsolicited adverse reactions after vaccination [ Time Frame: 28 days after vaccination ]
  2. Occurrence of serious adverse reaction during the whole follow-up period [ Time Frame: 6 months ]
  3. Post-vaccination Rate of infected with HIV [ Time Frame: 6 months ]
  4. Neutralizing antibody titers response to human Ad5 [ Time Frame: 14 days after vaccination ]
  5. Neutralizing antibody titers response to human Ad5 [ Time Frame: 28 days after vaccination ]
  6. Neutralizing antibody titers response to human Ad5 [ Time Frame: 168 days after vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18 and 50 years
  • Able to understand the content of informed consent and signed the informed consent
  • Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
  • Negative in HIV diagnostic blood test on day of enrollment
  • Axillary temperature ≤37.0°C on the day of enrollment
  • Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

  • Infected by Ebola virus (inquiry)
  • Vaccination with other Ebola vaccine (inquiry)
  • HIV infection or other serious immunodeficiency disease (inquiry)
  • Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
  • Family history of brain or mental disease
  • Woman who is pregnant or breast-feeding
  • Any acute fever disease or infections in last 7 days
  • Major congenital defects or not well-controlled chronic illness
  • Asplenia or functional asplenia
  • Platelet disorder or other bleeding disorder
  • 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 other research medicines in last 1 month
  • Prior administration of attenuated vaccine(s) in the last one month
  • Prior administration of inactivated vaccine(s) in the last 14 days
  • Any condition that in the opinion of the investigators may interfere with the participants' compliance or 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): NCT02575456


Locations
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Sierra Leone
Dr. Alie H Wurie
Freetown, Sierra Leone
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Investigators
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Principal Investigator: Alie H Wurie Ministry of Health & Sanitation
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02575456    
Other Study ID Numbers: JSVCT024
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections