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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

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 Type: Interventional
• Enrollment (Actual): 508
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse reactions	0-14 days post vaccination
Anti SARS-CoV-2 S IgG antibody response(ELISA)	28 days post vaccination
Neutralizing antibody response to SARS-CoV-2	28 days post vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events	0-28 days post vaccination
Occurrence of serious adverse reaction	0-6 months post vaccination
Anti SARS-CoV-2 S IgG antibody response(ELISA)	0, 14 days and 6 months post vaccination
Neutralizing antibody response to SARS-CoV-2	0 and 6 months post vaccination
Neutralizing antibody response to Ad5-vector	0, 28 days and 6 months post vaccination
IFN-γ ELISpot responses to SARS-CoV-2 spike protein	0 and 28 days post vaccination

Collaborators and Investigators

• Sponsor: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
• Collaborators: Zhongnan Hospital; Jiangsu Province Centers for Disease Control and Prevention; CanSino Biologics Inc.; Hubei Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Fengcai Zhu, MD, Jiangsu Province Centers of Disease Control and Prevention

Publications and helpful links

General Publications

• Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. 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. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19 vaccine; Ad5-nCoV
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JSVCT089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No