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）

Guangzhou Patronus Biotech Co., Ltd.1 site in 1 countryJanuary 7, 2023

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Guangzhou Patronus Biotech Co., Ltd.
Locations: 1
Primary Endpoint: Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 7, 2023

End Date

June 27, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Patronus Biotech Co., Ltd.

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain

Time Frame: Day 14 after full vaccination.

GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.

Secondary Outcomes

The occurrence of adverse events(30 mins,7 days and 28 days after each vaccination)
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain.(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)(Day 0 to 12 months after dose1and dose2)
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain(Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination)
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.(Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination)