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
Latest Information Update: 26 May 2023
At a glance
- Drugs Ad5-nCoV Tianjin CanSino Biotechnology (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; Pharmacodynamics
- Acronyms CTII-nCoV
Most Recent Events
- 22 May 2023 Status changed from active, no longer recruiting to completed.
- 20 Jul 2020 Results published in the THE LANCET
- 20 Apr 2020 Status changed from recruiting to active, no longer recruiting.
Trial Overview
Purpose
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.
Primary Endpoints
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
Other Endpoints
Occurrence of adverse events
time_frame: 0-28 days post vaccination
Occurrence of serious adverse reaction
time_frame: 0-6 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 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | prevention | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04341389 | Interferon Gamma (IFNg) | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 500
Actual: 508
- Sex male & female
- Age Group 18-60 years; adult
Patient 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.
Patient 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.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04341389 | ClinicalTrials.gov: US National Institutes of Health |
JSVCT089 | - |
Organisations
- Affiliations Tianjin CanSino Biotechnology
Trial Dates
-
Initiation Dates
Planned : 12 Apr 2020
Actual : 12 Apr 2020
-
Primary Completion Dates
Planned : 31 Jan 2021
Actual : 30 Nov 2020
-
End Dates
Planned : 31 Jan 2021
Actual : 31 Dec 2020
Other Details
- Design crossover; double-blind; prospective; randomised
- Phase of Trial Phase II
- Location China
- Focus Adverse reactions; Pharmacodynamics
Interventions
Drugs | Route | Formulation | Target |
---|---|---|---|
Ad5-nCoV Tianjin CanSino Biotechnology Primary Drug
|
Intramuscular | Injection |
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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
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
Arm 3
Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
Other: Placebo (Intramuscular injection) Other Name: Control
Results
Publications
-
Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Internet-Doc 2020;.
Available from: URL: https://doi.org/10.1016/S0140-6736(20)31605-6
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Fengcai Zhu, MD | Jiangsu Province Centers of Disease Control and Prevention |
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Centres
Centre Name | Location | Trial Centre Country |
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CanSino Biologics Inc. |
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|
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Hubei Provincial Center for Disease Control and Prevention |
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|
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Hubei Provincial Center for Disease Control and Prevention | Wuhan, Hubei | China |
Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China |
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|
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Jiangsu Province Centers for Disease Control and Prevention |
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|
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Jiangsu Province Centers of Disease Control and Prevention |
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|
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Zhongnan Hospital |
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|
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Trial History
Event Date | Event Type | Comment |
---|---|---|
26 May 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 26 May 2023 |
22 May 2023 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 26 May 2023 |
06 May 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified May 2020). Updated 06 May 2022 |
20 Jul 2020 | Results | Results published in the THE LANCET Updated 22 Jul 2020 |
18 May 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
20 Apr 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 22 Apr 2020 |
13 Apr 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 16 Apr 2020 |
13 Apr 2020 | New trial record | New trial record Updated 13 Apr 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2024;.
Available from: URL: http://clinicaltrials.gov -
Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Internet-Doc 2020;.
Available from: URL: https://doi.org/10.1016/S0140-6736(20)31605-6
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