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Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
COVID-19 Vaccine (Vero cell), Inactivated
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects aged 60 years and above;
  • Provide legal identification;
  • Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）；
  • Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.

Exclusion Criteria:

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research& Development Co., Ltd.;
  • History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
  • 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) in the past 6 months or plan to receive these treatments during the study period;
  • Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Yongde Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental group 1 (3-month interval)

Experimental group 2 (4-month interval)

Experimental group 3 (5-month interval)

Experimental group 4 (6-month interval)

Arm Description

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）.

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）.

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）.

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.

Outcomes

Primary Outcome Measures

Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies at 14 days after vaccination
Immunogenicity index- GMT of neutralizing antibodies
GMT of neutralizing antibodies at 28 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions 0~28 days after vaccination

Secondary Outcome Measures

Immunogenicity index-seropositive rate of neutralizing antibodies
Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies before vaccination and at different points after vaccination.
Immunogenicity index-4-fold increase rate of neutralizing antibodies
4-fold increase rate of neutralizing antibodies at different points after vaccination.
Safety index-Incidence of adverse reactions
Incidence of adverse reactions 0~7 days after vaccination.
Safety index-Incidence of serious adverse events
Incidence of serious adverse events 6 months after vaccination.

Full Information

First Posted
May 31, 2022
Last Updated
August 9, 2022
Sponsor
Sinovac Life Sciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05398926
Brief Title
Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly
Official Title
An Open Clinical Trial to Evaluate Immunogenicity and Safety of a Third Dose at Different Times After Two-dose of COVID-19 Vaccine (Vero Cell), Inactivated in the Elderly Aged 60 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.
Detailed Description
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research & Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1 (3-month interval)
Arm Type
Experimental
Arm Description
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）.
Arm Title
Experimental group 2 (4-month interval)
Arm Type
Experimental
Arm Description
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）.
Arm Title
Experimental group 3 (5-month interval)
Arm Type
Experimental
Arm Description
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）.
Arm Title
Experimental group 4 (6-month interval)
Arm Type
Experimental
Arm Description
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccine (Vero cell), Inactivated
Other Intervention Name(s)
CoronaVac®
Intervention Description
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.
Primary Outcome Measure Information:
Title
Immunogenicity index-GMT of neutralizing antibodies
Description
GMT of neutralizing antibodies at 14 days after vaccination
Time Frame
At 14 days after vaccination
Title
Immunogenicity index- GMT of neutralizing antibodies
Description
GMT of neutralizing antibodies at 28 days after vaccination
Time Frame
At 28 days after vaccination
Title
Safety index-Incidence of adverse reactions
Description
Incidence of adverse reactions 0~28 days after vaccination
Time Frame
0~28 days after vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index-seropositive rate of neutralizing antibodies
Description
Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination
Time Frame
Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies
Description
GMT of neutralizing antibodies before vaccination and at different points after vaccination.
Time Frame
Day 0 before vaccination and 180 days after vaccination
Title
Immunogenicity index-4-fold increase rate of neutralizing antibodies
Description
4-fold increase rate of neutralizing antibodies at different points after vaccination.
Time Frame
At 14 days and 28 days after vaccination.
Title
Safety index-Incidence of adverse reactions
Description
Incidence of adverse reactions 0~7 days after vaccination.
Time Frame
0~7 days after vaccination
Title
Safety index-Incidence of serious adverse events
Description
Incidence of serious adverse events 6 months after vaccination.
Time Frame
6 months after vaccination

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged 60 years and above; Provide legal identification; Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）； Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan. Exclusion Criteria: History of SARS-CoV-2 infection(laboratory confirmed); Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research& Development Co., Ltd.; History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema; 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) in the past 6 months or plan to receive these treatments during the study period; Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days; Onset of various acute or chronic diseases within 7 days prior to the study; Axillary temperature >37.0°C; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yang, Master
Organizational Affiliation
Yunnan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yongde Center for Diseases Control and Prevention
City
Lincang
State/Province
Yunnan
ZIP/Postal Code
677600
Country
China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly

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