Clinical trial NCT05313022: Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Walvax Biotechnology Co., Ltd.
First posted: 2022-04-06
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody
timeFrame: 28 days after each dose
measure: Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody
timeFrame: 28 days after each dose
measure: Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies
timeFrame: 28 days after each dose
measure: Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.
timeFrame: 28 days after each dose
measure: Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..
timeFrame: 28 days after each dose
measure: Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.
timeFrame: 28 days after each dose
Secondary outcomes:
measure: Incidence of adverse events (AEs) after vaccination
timeFrame: 28 days after the first or second vaccination
measure: Incidence of solicited adverse events (AEs) after vaccination
timeFrame: 30 minutes and 7 days after the first or second vaccination
measure: Incidence of unsolicited adverse events (AEs) after vaccination
timeFrame: 28 days after the first or second vaccination
measure: Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters
timeFrame: Day 4 after first or second vaccination
measure: Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
timeFrame: up to 12month after last dose vaccination
Other outcomes:
Locations:
city: Kunming
country: China
facility: Clinical Trial Institution for Anning First Hospital
state: Yunan
Study officials:
References: