Coronavirus Disease 2019 Clinical Trial
Official title:
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
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.
Overall design: In this study, a randomized, double-blind, parallel-controlled trial design was used to evaluate the inter-batch consistency of immunogenicity of the three batches of recombinant Novel Coronavirus vaccine (CHO cells) after process validation in 18-59 year olds and the non-inferiority of immunogenicity between the three batches after process validation and the pilot scale batches. Non-inferiority of immunogenicity between the three batches after process validation and the commercial scale batches (clinical trials have been conducted), and the safety of each vaccine batch after vaccination was evaluated. Intervention: Group A: 3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60; Group B: 3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; Group C: 3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; Group D: 3 doses of experimental vaccine (process validation lot 3) at day 0, 30 and 60; Immunogenicity observation:Blood samples were collected before the first dose and 14 days after the whole immunization, and the serum was separated for detection of live virus neutralizing antibodies (CPE method). Safety observation: (1) All adverse events (AE) were collected 30 minutes after each dose, all AE (including both solicitation and non-solicitation AE) at 0-7 days, and all AE (non-solicitation AE) at 8-30 days. Solicitation AE (the following events occurring within 7 days of vaccination) : 1. Adverse events at the inoculation site (local) : pain, swelling, induration, redness, rash, pruritus; 2. Vital signs: fever; 3. Non-inoculated site (systemic) adverse events: headache, fatigue/fatigue, nausea, vomiting, diarrhea, muscle pain (non-inoculated site), cough, acute allergic reactions. (2) All SAE were collected from the first dose to 12 months after full immunization. ;
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