Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19

A Randomized, Open, Control Phase ⅠV Clinical Trial, to Evaluate One Booster Immunization of Inactivated COVID-19 Vaccine (CoronaVac) or Original Vaccine in Adults Aged 18-45 Years Old Previously Vaccinated With Inactivated COVID-19 Vaccine From Difference Manufactures

This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine

Study Overview

• Status: Suspended
• Conditions: COVID-19
• Intervention / Treatment: Biological: Experimental vaccine 1; Biological: Experimental vaccine 2; Biological: Experimental vaccine 3

Detailed Description

This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Tongren, Guizhou, China, 565300
      • Yanhe Tujia Autonomous County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18-45;
• Proven legal identity;
• The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
• Have completed two doses of SARS-CoV-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).

Exclusion Criteria:

• History of SARS-CoV-2 infection(laboratory confirmed);
• Have received inactivated SARS-CoV-2 vaccine from other manufacturers other than Sinovac Life Sciences Co., Ltd.,Beijing Institute of Biological Products Co.,Ltd.and Wuhan Institute of Biological Products Co.,Ltd.and received three and more doses of inactivated SARS-CoV-2 vaccine;
• Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
• Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
• 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;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• History of alcohol or drug abuse;
• Receipt of blood products within in the past 3 months;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 14 days;
• Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
• Axillary temperature >37.0°C;

• Already pregnant or are breastfeeding, planning to get pregnant within

  1months (according to subjects' self-report and urine pregnancy test results);

• Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;
• 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1; 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd.	Biological: Experimental vaccine 1; Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Experimental: Experimental Group 2; 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd.	Biological: Experimental vaccine 1; Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Experimental: Experimental Group 3; 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd.	Biological: Experimental vaccine 2; Inactivated COVID-19 vaccine manufactured by Beijing Institute of Biological Products Co.,Ltd.4ug inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Experimental: Experimental Group 4; 92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd.	Biological: Experimental vaccine 1; Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Experimental: Experimental Group 5; 92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.	Biological: Experimental vaccine 3; Inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.200WU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-GMT of neutralizing antibodies	GMT of neutralizing antibody 28 days after booster dose.	28 days after booster dose
Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies	Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.	28 days after booster dose
Immunogenicity index-seropositive rate of neutralizing antibody	Seropositive rate of neutralizing antibody 28 days after booster dose.	28 days after booster dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-Incidence of adverse reactions	Incidence of adverse reactions occured 0-28 days after booster	0-28 days after booster
Safety index-Incidence of adverse reactions	Incidence of adverse reactions occurred 0-7 days after booster dose.	0-7 days after booster dose
Safety index-Incidence of SAEs and AESIs	Incidence of SAEs and AESIs occured 0-28 days after booster.	0-28 days after booster

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Qiuyue Mu, Master, Guizhou Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): March 20, 2023
• Study Completion (Anticipated): August 20, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: November 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-4012

Drug and device information, study documents

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