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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: 19 May 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 Apr 2020 Status changed from recruiting to active, no longer recruiting.
    • 13 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 13 Apr 2020 New trial record

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

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Fengcai Zhu, MD Jiangsu Province Centers of Disease Control and Prevention
-
Wenjuan Wang, MD
8625-83759911 wangwj@jscdc.cn
show details
-
Zhao Wang, MD
13476011311 markwangzhao@qq.com
show details
Hubei Provincial Center for Disease Control and Prevention China

Centres

Centre Name Location Trial Centre Country
-
-
-
CanSino Biologics Inc.
-
-
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 of Disease Control and Prevention
-
-
Zhongnan Hospital
-
-

Trial History

Event Date Event Type Comment
19 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 19 May 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
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