A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines

Livzon Pharmaceutical Group Inc.1 site in 1 country150 target enrollmentNovember 10, 2021

ConditionsCOVID-19 Pandemic

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19 Pandemic
Sponsor: Livzon Pharmaceutical Group Inc.
Enrollment: 150
Locations: 1
Primary Endpoint: Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines

Detailed Description

This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group. The random stratification factor is age (18-59 years old vs. ≥ 60 years old).

Registry

clinicaltrials.gov

Start Date

November 10, 2021

End Date

January 28, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Livzon Pharmaceutical Group Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy participants aged 18 years and older who have completed the second dose of 2-dose regimen of SARS-CoV-2 Inactivated Vaccine in the past 6 (±1) months;
•Voluntarily participate in the study and sign the informed consent form, who can provide valid ID and follow the study protocol requirement;
•In the past 14 days, no history of high or medium risk of the epidemic, overseas travel history or residence history; no history of contact with confirmed, asymptomatic or suspected COVID-19 cases; no history of contact with the persons from high- and medium-risk epidemic areas or contact patients with fever or respiratory symptoms; and those who are not in isolation period.
•Males of reproductive potential and females of childbearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 3 months after vaccination.

Exclusion Criteria

•Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR.
•History of previous SARS infection.
•History of severe allergy to any vaccine or any ingredient of the vaccine including aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc.
•People who currently suffer from the following diseases:
•Symptoms related to acute respiratory infections (such as: sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.)
•Patients with thrombocytopenia, any coagulation dysfunction, or receive anticoagulant treatment, etc.
•Patients with congenital or acquired angioedema/neuroedema;
•A history of congenital or acquired immunodeficiency or autoimmune disease (except for mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy); no spleen , or history of spleen surgery, history of trauma, or treatment with immunomodulators within 6 months, such as: glucocorticoid with the dose causing immunosuppressive (dose reference: equivalent to prednisone 20mg/day, more than one week); or monoclonal antibody ; or thymosin; or interferon, etc.; but local medication (such as ointment, eye drops, inhalation or nasal spray) is allowed.
•Patients with active tuberculosis, viral hepatitis, human immunodeficiency virus or syphilis infection.
•Patients with acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases: history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg) And/or diastolic blood pressure ≥100mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer (except for basal cell carcinoma), diabetes (unsatisfied blood sugar control or diabetes related serious complications).