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

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: NCT04341389
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : May 24, 2023
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):
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) Other: Placebo Phase 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 12, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1
1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
 Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
Intramuscular injection
Other Name: Ad5-nCoV
Active Comparator: Arm 2
5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
 Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
Intramuscular injection
Other Name: Ad5-nCoV
Placebo Comparator: Arm 3
Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
 Other: Placebo
Intramuscular injection
Other Name: Control


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of adverse reactions [ Time Frame: 0-14 days post vaccination ]
  2. Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 28 days post vaccination ]
  3. Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 28 days post vaccination ]

Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 0-28 days post vaccination ]
  2. Occurrence of serious adverse reaction [ Time Frame: 0-6 months post vaccination ]
  3. Anti SARS-CoV-2 S IgG antibody response(ELISA) [ Time Frame: 0, 14 days and 6 months post vaccination ]
  4. Neutralizing antibody response to SARS-CoV-2 [ Time Frame: 0 and 6 months post vaccination ]
  5. Neutralizing antibody response to Ad5-vector [ Time Frame: 0, 28 days and 6 months post vaccination ]
  6. IFN-γ ELISpot responses to SARS-CoV-2 spike protein [ Time Frame: 0 and 28 days post vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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): NCT04341389


Locations
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China, Hubei
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Sponsors and Collaborators
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
CanSino Biologics Inc.
Jiangsu Province Centers for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Zhongnan Hospital
Investigators
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Principal Investigator: Fengcai Zhu, MD Jiangsu Province Centers of 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: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
ClinicalTrials.gov Identifier: NCT04341389    
Other Study ID Numbers: JSVCT089
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China:
COVID-19 vaccine
Ad5-nCoV
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases