Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

Overall design: An open experimental design was adopted in this study, and 360 subjects were planned to be enrolled.To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine. Intervention: This study involved people 18 years of age and older.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). Immunogenicity observation: Blood samples were collected from all subjects before and 14 days after experimental vaccine vaccination for humoral immunoassay. Safety observation: AE and SAE: Collect all adverse events (AE) at least 30 minutes after vaccination, all AE (both solicitation and non-solicitation AE) from 0 to 7 days, and all AE (non-solicitation AE) from 8 to 30 days;All serious adverse events (SAE) within 1 month after vaccination with the experimental vaccine were collected. 1. Solicitation AE (the following events occurring within 0-7 days after vaccination with experimental vaccine) :Adverse events at the inoculation site (local) : pain, itching, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough. 2. Vital signs and physical examination:All subjects were assessed for vital signs (blood pressure, axillary body temperature, pulse) during screening and axillary body temperature before trial vaccination. All subjects underwent physical examination (skin, cardiopulmonary auscultation) during the screening period. 3. Collection of pregnancy events:Women of childbearing age should undergo a urine pregnancy test before enrollment (on the day of vaccination). Pregnancy events occurring within 1 month after trial vaccination were collected. 4. ADE/VED (Antibody enhancement/vaccine Enhancement) Risk Monitoring:After receiving the 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 local epidemic prevention and control requirements.A special investigation will be conducted for severe/critical/fatal cases, and the existence of ADE/VED will be analyzed based on the results of the special investigation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05089045
Study type Interventional
Source Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Contact
Status Completed
Phase N/A
Start date August 31, 2021
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05091411 - Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells) Phase 3
Completed NCT05107375 - Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza Vaccine Phase 3
Active, not recruiting NCT05128643 - Clinical Study on the Immune Program of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Phase 3
Completed NCT04988217 - Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) Phase 1/Phase 2
Completed NCT04579393 - Fostamatinib for Hospitalized Adults With COVID-19 Phase 2
Withdrawn NCT04390217 - LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia Phase 2
Recruiting NCT05047783 - Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 Phase 2
Completed NCT04646044 - A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 Phase 1
Not yet recruiting NCT06392451 - LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia N/A
Recruiting NCT05092568 - Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service
Completed NCT05364268 - Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation
Completed NCT06189040 - Immunogenicity After COVID-19 Vaccines in Adapted Schedules Phase 4
Recruiting NCT04401436 - COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
Not yet recruiting NCT04395742 - 1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
Recruiting NCT04388631 - Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health.
Completed NCT05501288 - Huashi Baidu Granule in the Treatment of Pediatric Patients With Mild Coronavirus Disease 2019 N/A
Active, not recruiting NCT05216471 - Identify Coronavirus Disease by Chest X-ray
Terminated NCT04672564 - Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients Phase 3
Completed NCT04967781 - Autoimmunity Contributes to the Severe Progression of COVID-19
Completed NCT04678830 - Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 Phase 2