Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: SARS-CoV-2 Inactivated Vaccine; Biological: The SARS-CoV-2 Inactivated Vaccine

Detailed Description

This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiang Wu, Master; Phone Number: 13381081732; Email: wj81732@hotmail.com

Study Locations

• China
  • Beijing, China, 100013
    • Recruiting
    • Beijing Centers for Diseases Control and Prevention
    • Contact: Jiang Wu, Master; Phone Number: 64407095; Email: wj81732@hotmail.com
    • Principal Investigator: Jiang Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults aged 18-59;
• Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd for group B;
• The subjects can understand and voluntarily sign the informed consent form;
• Proven legal identity.

Exclusion Criteria:

• History of SARS-CoV-2 infection;
• Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
• Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
• Autoimmune disease or immunodeficiency / immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization;
• Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
• Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
• Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
• Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
• Axillary temperature >37.0°C prior to booster vaccination;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 200 subjects in group A1 will receive one dose of booster immunization 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.	Biological: SARS-CoV-2 Inactivated Vaccine; 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection; Other Names: CoronaVac
Experimental: Control Group; 200 subjects in group A2 will receive one dose of booster immunization 5 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.	Biological: The SARS-CoV-2 Inactivated Vaccine; 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection; Other Names: CoronaVac
Experimental: Safety group; 1000 subjects in group B will be enrolled and receive 1 dose of booster immunization more than 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine	Biological: SARS-CoV-2 Inactivated Vaccine; 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection; Other Names: CoronaVac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2	GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.	1 month after booster immunization
Safety index-incidence of adverse reactions	Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine	1 month after booster immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-incidence of serious adverse events	Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine	1 month after booster immunization
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2	Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine	1 month after booster immunization
Seropositivity rate of IgG antibody	Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine	1 month after booster immunization

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2021
• Primary Completion (Actual): August 19, 2021
• Study Completion (Anticipated): December 19, 2021

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• 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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-nCOV-4003

Drug and device information, study documents

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