Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells)
Randomized, Double-blind, Parallel-controlled Evaluation of the Immunogenicity Consistency and Safety of the Three Batches of Recombinant Novel Coronavirus Vaccine (CHO Cells) After Process Verification in the 18-59-year-old Population, and the Comparison With the Pilot-scale Batch Immunogenicity Non-inferiority Bridging and Safety Clinical Trials
1 other identifier
interventional
1,680
1 country
1
Brief Summary
Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age. Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2021
CompletedFirst Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 25, 2021
October 1, 2021
2 months
October 12, 2021
October 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity endpoint
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 (4)
Population Ⅰ
EXPERIMENTAL3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60.
Population Ⅱ
EXPERIMENTAL3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60;
Population Ⅲ
EXPERIMENTAL3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60;
Population Ⅳ
EXPERIMENTAL3 doses of experimental vaccine (process validation lot 3) were given at day 0, 30 and 60.
Interventions
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Eligibility Criteria
You may qualify if:
- Persons aged 18-59 with full capacity for civil conduct;
- Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
- Female subjects of reproductive age agree to use effective contraceptive measures from the beginning of the study to 12 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;
- Diastolic blood pressure ≥100mmHg and/or systolic blood pressure ≥160mmHg before screening;
- 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 history of congenital or acquired immune deficiency or autoimmune disease; Received immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
- ③ Cancer patients (except basal cell carcinoma);
- ④ Patients with active tuberculosis, viral hepatitis and/or HIV antibody positive or syphilis specific antibody positive;
- ⑤ Neurological disease or family history (e.g., migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;
- ⑥ Functional absence of spleen, and absence of spleen or splenectomy caused by any reason;
- ⑦ Serious chronic diseases or diseases in the advanced stage can not be controlled smoothly, such as diabetes, thyroid diseases;
- ⑧ 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, cor pulmonale) or myocarditis or pericarditis.
- A history of severe allergy to any vaccine, or to any component of the test vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.;
- Subunit vaccine and inactivated vaccine should be administered within 14 days before the first dose of vaccine, and live attenuated vaccine should be administered within 30 days;
- Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned use from the beginning of the study to 1 month after full vaccination;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 411228, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tao Huang
Hunan Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 25, 2021
Study Start
September 9, 2021
Primary Completion
November 1, 2021
Study Completion
December 1, 2022
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share