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

NCT05128643 | Unknown Phase 3 DMC

• 1 other identifier: IIT-LKM-2021-NCV02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (1)

• Immunogenicity primary endpoint

  SARS-CoV-2 neutralizing antibody GMT

  14 days after full immunization

Secondary Outcomes (4)

• Immunogenicity secondary endpoint

  14 days after full immunization

• Immunogenicity secondary endpoint

  180 days after full immunization

• Safety endpoint

  One month after each dose

• Safety endpoint

  From the first dose to 6 months after full immunization

Study Arms (2)

Population Ⅰ

EXPERIMENTAL

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)

Population II

EXPERIMENTAL

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)

Interventions

Recombinant novel coronavirus vaccine (CHO cell) BIOLOGICAL

Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant novel coronavirus vaccine (CHO cells).

Population II; Population Ⅰ

Eligibility Criteria

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

You may qualify if:

• Persons over the age of 18 with full capacity for civil conduct;
• 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;
• 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.

You may not qualify if:

• Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
• 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;
• people who currently have or have a history of COVID-19;
• 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).
• had taken an antipyretic or painkiller within 24 hours before the first dose of vaccine;
• 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;
• Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned for use during the study period;

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (1)

Hunan Center for Disease Control and Prevention

Changsha, Hunan, 411228, China

Location

MeSH Terms

Conditions

COVID-19

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 Officials

• Huang Tao

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: November 22, 2021
• Study Start: September 17, 2021
• Primary Completion: April 12, 2022
• Study Completion: October 12, 2022
• Last Updated: February 22, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)