A Randomized, Blinded, Positive-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above

Guangzhou Patronus Biotech Co., Ltd.1 site in 1 country100 target enrollmentJuly 19, 2022

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: Guangzhou Patronus Biotech Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: The incidence of adverse reactions (ARs)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above.

Detailed Description

All subjects will be received 3 doses of LYB001, according to the immunization schedule of 0, 28, 56 days. The adverse events within 28 days after vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,day 14 after dose 2, and on day 14, 28 and month 3, 6, 9, 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

July 19, 2022

End Date

December 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Patronus Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18 years and above.
•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.
•Novel Coronavirus (COVID-19) Antibody (IgG and IgM) 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) infection or disease;
•History of COVID-19, or close contact with a confirmed/suspected COVID-19 patient, or SARS-CoV-2 nucleic acid test was positive or antibody test (IgG, IgM) was positive;
•Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
•Has received COVID-19 vaccine;
•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 during the 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.;

Outcomes

Primary Outcomes

The incidence of adverse reactions (ARs)

Time Frame: Day 0-7 days after each vaccination

The incidence of adverse reactions (ARs) within 7 days after each vaccination

Secondary Outcomes

The occurrence of adverse events(Day 0-28 days after each vaccination)
Seroconversion rate of of binding antibody against S protein of SARS-CoV-2 wild strain.(Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.)
The cytokine levels (Elispot): Th1 type: IL-2, IFN-γ; Th2 type: IL-4.(Day 14 after the second dose, day 14 after full vaccination.)
The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs)(Day 0 to 12 months after dose1, dose2 and dose 3.)
Laboratory safety measures: coagulation, blood biochemistry, complete blood count and urinalysis(Day 3 after each vaccination.)
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).(Day 14 after the second dose, 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 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.)
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).(Day 14 after the second dose, day 14, 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 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.)
GMFR of binding antibody against S protein of SARS-CoV-2 wild strain.(Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.)