NCT05128643

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Coronavirus Disease 2019

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-04-12
• Completion: 2022-10-12
• First posted: 2021-11-22
• Last updated: 2022-02-22

Locations

1 site across 1 country: China