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

NCT05313022 | Unknown Phase 1

• 1 other identifier: 202-COV-1003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Incidence of adverse events (AEs) after vaccination

  28 days after the first or second vaccination

• Incidence of solicited adverse events (AEs) after vaccination

  30 minutes and 7 days after the first or second vaccination

• Incidence of unsolicited adverse events (AEs) after vaccination

  28 days after the first or second vaccination

• Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters

  Day 4 after first or second vaccination

• Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)

  up to 12month after last dose vaccination

Study Arms (2)

ZR-202-CoV

EXPERIMENTAL

Adult healthy subjects (60 years of age above, inclusive) receive ZR-202-CoV at Day 0 and Day 28

Biological: ZR-202-CoV

Placebo

PLACEBO COMPARATOR

Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28

Other: Placebo

Interventions

ZR-202-CoV BIOLOGICAL

Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine

ZR-202-CoV

Placebo OTHER

Normal saline solution

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Liver function: ALT or ALT \> 1.25\*ULN
• Kidney function: serum creatinine (Cr) \> ULN
• 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);

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Walvax Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Clinical Trial Institution for Anning First Hospital

Kunming, Yunan, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

ZR-202-CoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: April 6, 2022
• Study Start: January 18, 2022
• Primary Completion: May 13, 2022
• Study Completion: June 1, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (1)