Immunogenicity and Safety Evaluation of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Enhancing Immunity

NCT05089045 | Completed

• 1 other identifier: LKM-2021-NCV04
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Popular topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine. Overall design:An open experimental design was used in this study Study population:The study involved people 18 years of age and older. Test groups: All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).

Conditions

Coronavirus Disease 2019

Keywords

Recombinant Novel Coronavirus Vaccine

Outcome Measures

Primary Outcomes (2)

• The number of adverse events after intramuscular injection

  The main observation methods of adverse reactions mainly include local reactions and systemic reactions at the administration site.

  1 months after full vaccination

• Immunogenic end point

  GMT and positive rate of SARS-COV-2 neutralizing antibody 14 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)

  14 days after vaccination

Study Arms (1)

Population Ⅰ

EXPERIMENTAL

Biological: Recombinant new coronavirus vaccine (CHO cell) group

Interventions

Recombinant new coronavirus vaccine (CHO cell) group BIOLOGICAL

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

Population Ⅰ

Eligibility Criteria

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

You may qualify if:

• Healthy subjects aged 18 and over with full civil capacity who can provide vaccination information proving that they have received two doses of Novel Coronavirus inactivated vaccine (Vero cells) in the last 3-13 months;
• Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
• Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex with an effective contraceptive method and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex).Subjects also agreed to use effective contraception from the time of signing informed consent to 1 month after trial vaccination.

You may not qualify if:

• History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
• SARS virus history;
• Fever caused by any reason (such as cold, local inflammation, tumor, rheumatic immune disease, etc.) within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
• history of severe allergic to any vaccine, or to test the vaccine's active ingredient, any a kind of active ingredients, use of material in the production process, including aluminum has a history of severe allergic, for example: the acute allergic reaction and allergic shock, allergic laryngeal edema, thrombocytopenic purpura, allergic purpura, difficulty breathing, angioneurotic oedema, etc;
• Persons suffering from the following diseases:
• ① Patients with stroke and encephalitis in the acute stage, patients with immune-related neurological diseases (such as myomyelitis, Guillanbarre syndrome, demyelinating disease, myasthenia gravis, etc.) that are not controlled, patients with epilepsy and severe mental illness, and patients with other neurological diseases that are not controlled;
• ② Patients with acute respiratory infection, acute attack of chronic obstructive pulmonary disease, acute attack of bronchial asthma or clinical uncontrolled stage, acute stage of pleural disease, etc.;
• ③ systolic blood pressure ≤90mmHg and/or diastolic blood pressure ≤60mmHg of unknown cause;Hypertension treated with lifestyle adjustment and/or medication, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg;Severe coronary heart disease, arrhythmia, heart rate less than 60 beats/min or more than 100 beats/min;Serious heart valve disease, aortic dissection, venous thrombosis;Patients with severe heart failure;Severe arrhythmia, or patients with acute coronary syndrome, acute aortic syndrome, etc.;
• ④ patients with acute pancreatitis, acute intestinal obstruction, acute hepatitis, patients with gastrointestinal bleeding symptoms, active stage of inflammatory bowel disease, active stage of chronic hepatitis, active stage of tuberculosis, etc.;
• ⑤ Patients with acute urinary and reproductive system infection, patients with severe kidney disease (uncontrolled acute and chronic nephritis, patients who are using glucocorticoids, immunosuppressants or biological agents, patients with acute renal insufficiency or chronic kidney disease stage 3 or more namely glomerular filtration rate eGFR\<60ml/min);
• ⑥ Diabetes patients with acute complications (remunerative acidosis, hyperotonic state, lactic acidosis) or with the above acute complications recovered less than 2 weeks;Fasting blood glucose \> 13.9 mmol/L;Hypothyroidism TSH \& GT;10 µ IU/L, with T3 and T4 lower than normal;Patients with uncontrolled hyperthyroidism or hyperthyroidism;
• ⑦ lymphoproliferative disease uncontrolled period, aplastic anemia not alleviated period, primary immune thrombocytopenia (ITP) activity period, coagulation disease uncontrolled period and other patients;
• ⑧ Was immune system disease (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.) in active patients, patients with congenital or acquired immunodeficiency, clear merge opportunistic infections or malignant tumors uncontrolled HIV infection, patients with lymphoma, leukemia or autoimmune inflammatory disease;
• ⑨ Patients with malignant tumor undergoing chemotherapy, radiotherapy, and immunotherapy before and after surgery;Patients with organ transplant status;
• ⑩ Patients with acute stage of severe allergic rhinitis, acute and chronic eczema or urticaria with obvious symptoms and signs, or patients with other skin symptoms;

Sponsors & Collaborators

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

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 411228, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Population Groups

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Tao Huang

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: August 31, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 30, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)