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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: ZR-202-CoV; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunan
    • Kunming, Yunan, China
      • Clinical Trial Institution for Anning First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZR-202-CoV; Adult healthy subjects (60 years of age above, inclusive) receive ZR-202-CoV at Day 0 and Day 28	Biological: ZR-202-CoV; Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine
Placebo Comparator: Placebo; Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28	Other: Placebo; Normal saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody	28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody	28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies	28 days after each dose
Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.	28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..	28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.	28 days after each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
• Collaborators: Walvax Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): May 13, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 202-COV-1003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No