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Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
One dose group
Two doses group
Aged 18-59 years
Aged 60 years old and above
Sponsored by
Guangzhou Patronus Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria: People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening). Participate the trial voluntarily and sign informed consent form. Subjects are willing to comply with the requirements of the clinical trial protocol and complete the study follow-up. Armpit temperature ≤37.0℃ on the day of enrollment. 2019 Novel Coronavirus (COVID-19) Antibody was negative. Exclusion Criteria: Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) or COVID-19 infection or disease; Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; Patients with the following diseases: Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; Positive for anti-AIDS antibody; Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; Asplenia or functional asplenia; Serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; Contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) . History of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; Participating or will participate other clinical trials during this trial; Any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. Women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;

Sites / Locations

  • Jiangsu Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low-dose vaccine

High-dose vaccine

Positive control

Arm Description

30μg LYB001 is to be used in the clinical trial. The number of each arm is 60.

60μg LYB001 is to be used in the clinical trial. The number of each arm is 60.

Positive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60.

Outcomes

Primary Outcome Measures

Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.

Secondary Outcome Measures

The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1 and dose2
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 7, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day14, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.
GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain.
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.

Full Information

First Posted
December 22, 2022
Last Updated
September 24, 2023
Sponsor
Guangzhou Patronus Biotech Co., Ltd.
Collaborators
Yantai Patronus Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05663086
Brief Title
Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above
Official Title
A Randomized, Blinded, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above(Negative for Antibody Against COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
According to the development of the novel coronavirus epidemic situation and the company's R&D decision
Study Start Date
January 7, 2023 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Patronus Biotech Co., Ltd.
Collaborators
Yantai Patronus Biotech 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
Yes

5. Study Description

Brief Summary
This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above(negative antibody against COVID-19). 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.
Detailed Description
Subjects will receive 1 dose or 2 doses of LYB001, according to the immunization schedule of 0 day or 0, 28 days. The adverse events within 28 days after each vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,and on day 7, 14, 28 and month 3, 6, 12 after full vaccination. Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose vaccine
Arm Type
Experimental
Arm Description
30μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
Arm Title
High-dose vaccine
Arm Type
Experimental
Arm Description
60μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
Arm Title
Positive control
Arm Type
Active Comparator
Arm Description
Positive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60.
Intervention Type
Biological
Intervention Name(s)
One dose group
Intervention Description
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Intervention Type
Biological
Intervention Name(s)
Two doses group
Intervention Description
The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Intervention Type
Biological
Intervention Name(s)
Aged 18-59 years
Intervention Description
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Intervention Type
Biological
Intervention Name(s)
Aged 60 years old and above
Intervention Description
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Primary Outcome Measure Information:
Title
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Description
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.
Time Frame
Day 14 after full vaccination.
Secondary Outcome Measure Information:
Title
The occurrence of adverse events
Description
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
Time Frame
30 mins,7 days and 28 days after each vaccination
Title
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Description
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1 and dose2
Time Frame
Day 0 to 12 months after dose1and dose2
Title
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Description
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 7, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Time Frame
Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination
Title
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Description
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day14, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Title
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Description
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Title
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Description
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Title
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.
Description
GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Title
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Description
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Title
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain.
Description
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time Frame
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening). Participate the trial voluntarily and sign informed consent form. Subjects are willing to comply with the requirements of the clinical trial protocol and complete the study follow-up. Armpit temperature ≤37.0℃ on the day of enrollment. 2019 Novel Coronavirus (COVID-19) Antibody was negative. Exclusion Criteria: Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) or COVID-19 infection or disease; Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; Patients with the following diseases: Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; Positive for anti-AIDS antibody; Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; Asplenia or functional asplenia; Serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; Contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) . History of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; Participating or will participate other clinical trials during this trial; Any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. Women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above

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