Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

COVID-19 Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 60 Years and Above

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05313022
• Other study ID #: 202-COV-1003
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 18, 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Shanghai Zerun Biotechnology Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: June 2023
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Having understood the contents of the clinical study and ICF, and having signed the ICF.

• Adults of both genders, 60 years of age and older.

• Adults who can provide legal proof of identity.

• SARS-COV-2 antibody screening negative at screening visit.

Exclusion Criteria:

• Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries);

• Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries);

• Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine;

• Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination);

• Axillary body temperature =37.3? before the first dose vaccination(examination);

• Safety laboratory abnormal of any of the below:

1. Liver function: ALT or ALT > 1.25*ULN

2. Kidney function: serum creatinine (Cr) > ULN

3. Glycated hemoglobin (HbA1c) = 8.0%

• Uncontrolled epilepsy or other progressive neurological diseases (inquiries);

• Immunocompromised or have been diagnosed with Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic lupus erythematosus, SLE, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases (inquiries);

• Asplenia or functional asplenia (inquiries);

• Having a history of coagulation disorder or abnormal coagulation function (e.g., lack of coagulation factors or thrombocytopenia) and assessed by investigators that are not suitable for the study (inquiry);

• Having malignant tumor that not been cured clinically and been assessed by investigators as not suitable for the study (inquiry);

• Having acute diseases or acute onset or poorly controlled chronic diseases(e.g. hypertension patients with blood pressure > 160/100mmHg, diabetes patients with ketoacidosis, etc.) within 14 days before the first dose vaccination and assessed by investigators as not suitable for the study (inquiry);

• Use of systemic drugs that affect immune function within 6 months prior to the first dose vaccination for a long time (more than 14 consecutive days), such as immunosuppressant, cytotoxic drugs, inhaled corticosteroids (not including allergic rhinitis treated with corticosteroid spray), unless the investigators determines that the drug will not interfere with, limit, or obfuscate the evaluation prescribed by the protocol, or may endanger the safety of the subject (inquiry);

• Treatment with whole blood, plasma or immunoglobulin within 3 months prior to the first dose(inquiry);

• Any other factors that, in the investigator's judgment, are inappropriate for participation in the clinical study.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• ZR-202-CoV
Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine

Other:
• Placebo
Normal saline solution

Locations

Country	Name	City	State
China	Clinical Trial Institution for Anning First Hospital	Kunming	Yunan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zerun Biotechnology Co.,Ltd	Walvax Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody		28 days after each dose
Primary	Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody		28 days after each dose
Primary	Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies		28 days after each dose
Primary	Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.		28 days after each dose
Primary	Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..		28 days after each dose
Primary	Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.		28 days after each dose
Secondary	Incidence of adverse events (AEs) after vaccination	Percentage of participants with AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.	28 days after the first or second vaccination
Secondary	Incidence of solicited adverse events (AEs) after vaccination	Percentage of participants with solicited AEs for 30 minutes and 7 days following each vaccination (Days 0, 28) by intensity, relevance	30 minutes and 7 days after the first or second vaccination
Secondary	Incidence of unsolicited adverse events (AEs) after vaccination	Percentage of participants with unsolicited AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.	28 days after the first or second vaccination
Secondary	Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters	Safety Laboratory Values (Serum Chemistry, Hematology)	Day 4 after first or second vaccination
Secondary	Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)	Percentage of participants with SAEs or AESIs for 12month after last dose vaccination	up to 12month after last dose vaccination