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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2020

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

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

  1. 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
-

Centres

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. 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. 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

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. 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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