Clinical Study on the Immune Program of Recombinant Novel Coronavirus（COVID-19) Vaccine (CHO Cell)

Clinical Study on the Immunogenicity and Safety of the Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) 0-1-6 Month and 0-1-4 Month Immunization Programs in People Aged 18 and Above

Popular topic：Clinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of the investigational vaccine in people aged 18 and above.

Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety.

Study population:The study involved people 18 years of age and older. Test groups：A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronavirus Disease 2019
• Intervention / Treatment: Biological: Recombinant novel coronavirus vaccine (CHO cell)

Detailed Description

Overall design:In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety.

Intervention: A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).

Immunogenicity observation:

About 5.0mL of venous blood was collected from all subjects for immunogenicity test before the first dose, before the third dose, on day 14 and 180 after full immunization.

Safety observation:

All adverse events (AE) were collected within 30 minutes after each dose, all AEs (both solicited and unsolicited) were collected 0-7 days after each dose, and all AEs (unsolicited) were collected 8-30 days after each dose. All SAEs were collected from the first dose up to 6 months after full immunization.

Solicited AEs (the following events occurring within 7 days of vaccination) :

Adverse events at the inoculation site (local) : pain, swelling, induration, redness, rash, pruritus; Vital signs: fever; Non-inoculated site (systemic) adverse events: headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough.

Vital signs and physical examination:

1. All subjects underwent a daily armpit temperature examination during the screening period, before subsequent doses, and within 7 days after each dose.
2. All subjects underwent physical examination (skin and cardiopulmonary auscultation) and blood pressure measurement during the screening period.

ADE/VED (Antibody Enhancement/vaccine Enhancement disease) Risk Monitoring:

After vaccination (at least one dose of experimental vaccine), if the subject is diagnosed with COVID-19, he/she should go to the hospital for hospitalization or be isolated in accordance with the epidemic prevention and control requirements of the area in which he/she is located. A special investigation should be conducted for the existence of ADE/VED in severe/critical cases/deaths.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 411228
      • Hunan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Persons over the age of 18 with full capacity for civil conduct;
2. The subject voluntarily agrees to participate in the study and signs the informed consent, and can provide valid identification, understand and comply with the requirements of the study protocol;
3. Fertile male and female subjects of reproductive age agreed to use effective contraceptive measures from the beginning of the study to 2 months after full vaccination.

Exclusion Criteria:

1. Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
2. Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.; Or have a history of severe adverse reactions to any of the above mentioned vaccines or medications;
3. people who currently have or have a history of COVID-19;

4. Persons suffering from the following diseases:

   ① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;

   ② Congenital or acquired immune deficiency or autoimmune disease history or received immunomodulatory treatment within 6 months Treatment, such as immunosuppressive doses of glucocorticoid (dose reference: equivalent to prednisone 20mg/ day, more than one weeks); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical application (e.g. ointments, eye drops) is allowed Liquid, inhalant or nasal spray);

   ③ Have been diagnosed with a known infectious disease, such as active tuberculosis, viral hepatitis, human immunodeficiency virus or treponema pallidum;

   ④ Neurological disorders (e.g., convulsions, migraines, epilepsy, stroke, epileptic seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;

   ⑤ functional absence of spleen, and absence of spleen or splenectomy caused by any reason;

   ⑥ There are serious chronic diseases or diseases in the progressive stage can not be controlled smoothly, such as diabetes, drugs can not control Hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);

   ⑦ Severe liver and kidney diseases; Any current respiratory illness requiring routine medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any exacerbation of respiratory illness (e.g., exacerbation of asthma) within the last 5 years; A history of serious cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;

   ⑧ Cancer patients (except basal cell carcinoma).

5. had taken an antipyretic or painkiller within 24 hours before the first dose of vaccine;
6. Those who have received novel coronavirus vaccine, or subunit vaccine and/or inactivated vaccine within 7 days before the first dose, or live attenuated vaccine within 14 days;
7. Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned for use during the study period;
8. Lactating or pregnant women (including women of childbearing age who have positive urine pregnancy test), or women who plan to have a pregnancy within 2 months after full vaccination of the test vaccine or their partners;
9. Have participated in or are currently participating in other COVID-19 related clinical trials;
10. The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Population Ⅰ; At 0,1,6 months, 3 doses of experimental vaccine were injected into the deltoid muscle of the upper arm.	Biological: Recombinant novel coronavirus vaccine (CHO cell); Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant novel coronavirus vaccine (CHO cells).
Experimental: Population II; At 0,1,4 months, 3 doses of experimental vaccine were injected into the deltoid muscle of the upper arm.	Biological: Recombinant novel coronavirus vaccine (CHO cell); Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant novel coronavirus vaccine (CHO cells).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity primary endpoint	SARS-CoV-2 neutralizing antibody GMT	14 days after full immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity secondary endpoint	positive conversion rate, positive rate, GMI of SARS-CoV-2 neutralizing antibody, RBD protein binding antibody (IgG); GMT of RBD protein binding antibody (IgG)	14 days after full immunization
Immunogenicity secondary endpoint	positive rate, GMT of SARS-CoV-2 neutralizing antibody, RBD protein binding antibody (IgG)	180 days after full immunization
Safety endpoint	All adverse events (AEs)	One month after each dose
Safety endpoint	Incidence of all serious adverse events (SAEs)	From the first dose to 6 months after full immunization

Collaborators and Investigators

• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Investigators: Principal Investigator: Huang Tao, Hunan Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Anticipated): April 12, 2022
• Study Completion (Anticipated): October 12, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: IIT-LKM-2021-NCV02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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