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

At a glance

Drugs Ad5-nCoV Tianjin CanSino Biotechnology (Primary)
Indications COVID 2019 infections
Focus Adverse reactions; Pharmacodynamics
Acronyms CTII-nCoV

Most Recent Events

20 Jul 2020 Results published in the THE LANCET
20 Apr 2020 Status changed from recruiting to active, no longer recruiting.
13 Apr 2020 Status changed from not yet recruiting to 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	-

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
End Dates
Planned : 31 Jan 2021

Other Details

Design crossover; double-blind; prospective; randomised
Phase of Trial Phase II
Location China
Focus Adverse reactions; Pharmacodynamics

Drug Name	Highest Phase	Originator
Ad5 nCOV - Tianjin CanSino Biotechnology	Phase III	Tianjin CanSino Biotechnology

Interventions

Drugs	Route	Formulation
Ad5-nCoV Tianjin CanSino BiotechnologyPrimary Drug	Intramuscular	Injection

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

Download Data (CSV)

Investigator	Centre Name	Trial Centre Country
Fengcai Zhu, MD	Jiangsu Province Centers of Disease Control and Prevention	-

Centres

Download Data (CSV)

Centre Name	Location	Trial Centre Country
CanSino Biologics Inc.	-	-
Hubei Provincial Center for Disease Control and Prevention	-	-
Hubei Provincial Center for Disease Control and Prevention	Wuhan, Hubei	China
Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China	-	-
Jiangsu Province Centers for Disease Control and Prevention	-	-
Jiangsu Province Centers of Disease Control and Prevention	-	-
Zhongnan Hospital	-	-

Trial History

Event Date	Event Type	Comment
17 Sep 2020	Other trial event	Last checked against ClinicalTrials.gov record. ClinicalTrials.gov: US National Institutes of Health Updated 17 Sep 2020
20 Jul 2020	Results	Results published in the THE LANCET Updated 22 Jul 2020
20 Apr 2020	Status change - active, no longer recruiting	Status changed from recruiting to active, no longer recruiting. ClinicalTrials.gov: US National Institutes of Health Updated 22 Apr 2020
13 Apr 2020	Status change - recruiting	Status changed from not yet recruiting to recruiting. ClinicalTrials.gov: US National Institutes of Health Updated 16 Apr 2020
13 Apr 2020	New trial record	New trial record ClinicalTrials.gov: US National Institutes of Health Updated 13 Apr 2020

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