Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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 .

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 481 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : October 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MID A
20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Placebo Comparator: MID B
10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV

Experimental: MIN A
100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Placebo Comparator: MIN B
50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV

Experimental: OLD A
100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Experimental: OLD B
100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Placebo Comparator: OLD C
50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV

Experimental: EBOV A
34 participants, Ad5-nCoV , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Placebo Comparator: EBOV B
17 participants, Ad5-nCoV , two doses, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV




Primary Outcome Measures :
  1. Safety indexes of adverse reactions [ Time Frame: within 14 days post each vaccination ]
    Occurrence of adverse reactions post vaccination

  2. Immunogencity indexes of GMT [ Time Frame: Day 28 post the second vaccination ]
    Evaluate the Geometric mean titer (GMT) of IgG antibody

  3. Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the second vaccination ]
    Evaluate the Geometric mean titer (GMT) of neutralizing antibody


Secondary Outcome Measures :
  1. Safety indexes of adverse events [ Time Frame: Day 0-7,0-14,0-28 post each vaccination ]
    Occurrence of adverse reactions post-vaccination

  2. 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)

  3. 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)

  4. Safety indexes of SAE [ Time Frame: Within 6 months post the second vaccination ]
    Occurrence of serious adverse events post-vaccination

  5. 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

  6. 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

  7. 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)



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.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04566770


Contacts
Layout table for location contacts
Contact: Wenjuan Wang, MSD 025-83759911 wangwj@jscdc.cn

Locations
Layout table for location information
China, Jiangsu
Taixing City center for Disease Control and Prevention Recruiting
Taizhou, Jiangsu, China, 210000
Contact: Wenjuan Wang, MSD         
Sponsors and Collaborators
CanSino Biologics Inc.
Beijing Institute of Biotechnology
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Fengcai Zhu, MSD Jiangsu Provincal Center for Disease Control and Prevention
Layout table for additonal information
Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04566770    
Other Study ID Numbers: JSVCT093
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
COVID-19
Vaccine
Ad5
Safety
Immunogencity
SARS-CoV-2
Adenovirus Vector
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs