Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel

Status Not yet recruiting

Clinical Trial Summary

Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells). Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Overall design: Studies were randomized, double-blind, active-controlled study design. Study group: There were 160 participants aged 18 years and older, including 80 people aged 60 years and older. Study group：Among them, 80 subjects were from the "randomized, double-blind, active-controlled clinical study to evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged 18 years and older, protocol number: LKM-2023-NCV-02", 40 cases in the study group and 40 cases in the control group, and completed the second dose of vaccine at the 6th month visit to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the 1:1 ratio into the research group and the control group and received 2 doses of the experimental vaccine according to the 0-1-month procedure to observe immunogenicity and safety.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06025812
Study type	Interventional
Source	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Contact	Xie Hai Tang
Phone	0553-5738350
Email	xiehaitang@sina.com
Status	Not yet recruiting
Phase	N/A
Start date	September 20, 2023
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05065827` - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting	`NCT05359770` - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19	N/A
Completed	`NCT04515147` - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19	Phase 2
Recruiting	`NCT05289115` - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS	N/A
Completed	`NCT04779138` - Increasing Vaccine Uptake in Underresourced Public Housing Areas	N/A
Completed	`NCT04953078` - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19	Phase 1
Not yet recruiting	`NCT05868239` - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study	N/A
Completed	`NCT04818164` - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed	`NCT04690413` - NOWDx Test for the Detection of Antibodies to COVID-19	N/A
Terminated	`NCT04530448` - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization	Phase 4
Completed	`NCT04572399` - UVA Light Device to Treat COVID-19	N/A
Recruiting	`NCT04610567` - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19)	Phase 1/Phase 2
Completed	`NCT04551911` - Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19	Phase 2
Recruiting	`NCT04772170` - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting	`NCT04581954` - Inflammatory Signal Inhibitors for COVID-19 (MATIS)	Phase 1/Phase 2
Completed	`NCT04405934` - COG-UK Project Hospital-Onset COVID-19 Infections Study	N/A
Enrolling by invitation	`NCT04484025` - SPI-1005 Treatment in Moderate COVID-19 Patients	Phase 2
Completed	`NCT05572840` - Wear Your Mask, Wash Your Hands, Don't Get COVID-19	N/A
Withdrawn	`NCT04838847` - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19	Phase 3
Terminated	`NCT04371978` - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms