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

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ClinicalTrials.gov Identifier: NCT02533791
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : October 14, 2015
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV) Biological: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: low dose group
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
 Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
one dose, 4×10^10vp/1ml per dose
Experimental: high dose group
1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
 Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
Placebo Comparator: placebo group
placebo
 Biological: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of adverse reactions after vaccination [ Time Frame: within 7 days after the boosting ]
    Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  2. Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) [ Time Frame: 28 days after the boosting ]
    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA

  3. Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) [ Time Frame: 28 days after the boosting ]
    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV)


Secondary Outcome Measures :
  1. Occurrence of adverse events after the vaccination [ Time Frame: within 28 days after the boosting ]
    Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  2. Occurrence of serious adverse events after the vaccination [ Time Frame: within 28 days after the boosting ]
    Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

  3. Serum neutralizing antibody against the Ad5-vector [ Time Frame: 28 days after the boosting ]
    Serum neutralizing antibody against the Ad5-vector 28 days after the boosting


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT02533791


Locations
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China, Jiangsu
Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
Taizhou, Jiangsu, China
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: Feng-Cai Zhu Jiangsu Provincial Center for Disease Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02533791    
Other Study ID Numbers: JSVCT020-2
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety
immunogenicity
Ebola vaccine
boosting
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
 Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs