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Phase IIb Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

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ClinicalTrials.gov Identifier: NCT04566770
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
CanSino Biologics Inc.

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE September 24, 2020
Estimated Primary Completion Date August 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • Safety indexes of adverse reactions [ Time Frame: within 14 days post each vaccination ]
    Occurrence of adverse reactions post vaccination
  • Immunogencity indexes of GMT [ Time Frame: Day 28 post the second vaccination ]
    Evaluate the Geometric mean titer (GMT) of IgG antibody
  • Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the second vaccination ]
    Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • Safety indexes of adverse events [ Time Frame: Day 0-7,0-14,0-28 post each vaccination ]
    Occurrence of adverse reactions post-vaccination
  • Safety indexes of Hematological examination measures [ Time Frame: pre-vaccination, day 4 post each vaccination ]
    Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
  • Safety indexes of Blood routine measures [ Time Frame: pre-vaccination, day 4 post each vaccination ]
    Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
  • Safety indexes of SAE [ Time Frame: Within 6 months post the second vaccination ]
    Occurrence of serious adverse events post-vaccination
  • Immunogencity indexes of GMT [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
    Evaluate the Geometric mean titer of IgG antibody
  • Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
    Evaluate the Geometric mean titer (GMT) of neutralizing antibody
  • Immunogencity indexes of cellular immune [ Time Frame: Day 28 post the first vaccination, pre and day 28 post the second vaccination ]
    Number of cell-mediated immune response against SARS-CoV-2(IL-2)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IIb Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Official Title  ICMJE A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV
Brief Summary This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
Detailed Description

This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.

The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .

The immunization schedule is two doses intramuscular injections (deltoid).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    Intramuscular other name:Ad5-nCoV
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
    Intramuscular other name:Ad5-nCoV
Study Arms  ICMJE
  • Experimental: MID A
    20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: MID B
    10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
  • Experimental: MIN A
    100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: MIN B
    50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
  • Experimental: OLD A
    100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Experimental: OLD B
    100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: OLD C
    50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
  • Experimental: EBOV A
    34 participants, Ad5-nCoV , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: EBOV B
    17 participants, Ad5-nCoV , two doses, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2020)
481
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 20, 2022
Estimated Primary Completion Date August 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years and above in OLD group; aged in EBO group is not limited.
  • 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 6 months study follow-up period.
  • Negative in HIV diagnostic test.
  • Negative in serum antibodies (IgG and IgM) screening of COVID-19.
  • Axillary temperature ≤37.0°C.
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

  • Family history of seizure, epilepsy, brain or mental disease
  • Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
  • 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.
  • History of SARS
  • Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
  • Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year
  • No spleen or functional spleen.
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • Faint at the sight of 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
  • According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wenjuan Wang, MSD 025-83759911 wangwj@jscdc.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04566770
Other Study ID Numbers  ICMJE JSVCT093
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CanSino Biologics Inc.
Study Sponsor  ICMJE CanSino Biologics Inc.
Collaborators  ICMJE
  • Beijing Institute of Biotechnology
  • Jiangsu Province Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Fengcai Zhu, MSD Jiangsu Provincal Center for Disease Control and Prevention
PRS Account CanSino Biologics Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP