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A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) (CTII-nCoV)

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ClinicalTrials.gov Identifier: NCT04341389
Recruitment Status : Active, not recruiting
First Posted : April 10, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
CanSino Biologics Inc.
Jiangsu Province Centers for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Zhongnan Hospital
Information provided by (Responsible Party):
Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE April 12, 2020
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
  • Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 28 days post vaccination ]
  • Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
  • Anti SARS-CoV-2 S antibody response(ELISA) [ Time Frame: 28 days post vaccination ]
  • Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Occurrence of adverse events [ Time Frame: 0-28 days post vaccination ]
  • Occurrence of serious adverse reaction [ Time Frame: 0-6 months post vaccination ]
  • Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 0, 14 days and 6 months post vaccination ]
  • Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 0 and 6 months post vaccination ]
  • Neutralizing antibody response to Ad5-vector [ Time Frame: 0, 28 days and 6 months post vaccination ]
  • IFN-γ ELISpot responses to SARS-CoV-2 spike protein [ Time Frame: 0 and 28 days post vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Occurrence of adverse events [ Time Frame: 0-28 days post vaccination ]
  • Occurrence of serious adverse reaction [ Time Frame: 0-6 months post vaccination ]
  • Anti SARS-CoV-2 S antibody response(ELISA) [ Time Frame: 14 days, 6 months post vaccination ]
  • Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 6 months post vaccination ]
  • Neutralizing antibody response to Ad5-vector [ Time Frame: 28 days, 6 months post vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years
Brief Summary This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
Detailed Description This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
    Intramuscular injection
    Other Name: Ad5-nCoV
  • Other: Placebo
    Intramuscular injection
    Other Name: Control
Study Arms  ICMJE
  • Active Comparator: Arm 1
    1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
    Intervention: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
  • Active Comparator: Arm 2
    5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
    Intervention: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
  • Placebo Comparator: Arm 3
    Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
    Intervention: Other: 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2020)
508
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
500
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 and 60 years.
  • 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.
  • The BMI index is 18.5-30.0.
  • 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 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341389
Other Study ID Numbers  ICMJE JSVCT089
Has Data Monitoring Committee Yes
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 Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Study Sponsor  ICMJE Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Collaborators  ICMJE
  • CanSino Biologics Inc.
  • Jiangsu Province Centers for Disease Control and Prevention
  • Hubei Provincial Center for Disease Control and Prevention
  • Zhongnan Hospital
Investigators  ICMJE
Principal Investigator: Fengcai Zhu, MD Jiangsu Province Centers of Disease Control and Prevention
PRS Account Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Verification Date May 2020

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