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

NCT05165732 | Suspended Phase 4

• 1 other identifier: PRO-nCOV-4012
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Safety index-Incidence of adverse reactions

  0-28 days after booster

• Safety index-Incidence of adverse reactions

  0-7 days after booster dose

• Safety index-Incidence of SAEs and AESIs

  0-28 days after booster

Study Arms (5)

Experimental Group 1

EXPERIMENTAL

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

Experimental Group 2

EXPERIMENTAL

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

Experimental Group 3

EXPERIMENTAL

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

Experimental Group 4

EXPERIMENTAL

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

Experimental Group 5

EXPERIMENTAL

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

Interventions

Experimental vaccine 1 BIOLOGICAL

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 Group 1; Experimental Group 2; Experimental Group 4

Experimental vaccine 2 BIOLOGICAL

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 Group 3

Experimental vaccine 3 BIOLOGICAL

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.

Experimental Group 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Yanhe Tujia Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, 565300, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Qiuyue Mu, Master

  Guizhou Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 21, 2021
• Study Start: December 20, 2022
• Primary Completion: March 20, 2023
• Study Completion: August 20, 2023
• Last Updated: August 11, 2022

Record last verified: 2021-11

Locations

CN (1)