The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.
The improved vaccine was developed against the Delta and Omicron COVID-19 variants. The overall design of this clinical trial was as follows: A total of 300 patients aged 18 and above who completed the basic immunization of recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months were randomly divided into the experimental group and the control group in a blind way, and were inoculated with the experimental vaccine and the control vaccine respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine. The main objective was to evaluate the immunogenicity and safety of Omicron-Delta recombinant novel coronavirus protein vaccine (CHO cells) against Omicron variants of novel coronavirus in people aged 18 years and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
The antigen protein of this product is designed to be expressed in tandem with Delta variant R319-N356 and Omicron variant R319-N356. The antigen is called DO-RBD for short.
This strain was made from the NCP-RBD receptor binding region of the spike glycoprotein of novel coronavirus expressed in recombinant CHO cells, which was purified and added with aluminum hydroxide adjuvant
Uzbekistan, Tashkent city, Said baraka street 10
Tashkent, Uzbekistan
RECRUITINGImmunogenic end points
Geometric mean concentration (GMC) of RBD protein-binding Antibody (IgG) against Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group.
Time frame: 6 months
Immunogenic end points 2
RBD protein-bound antibody (IgG) growth ratio (GMI) and positive turnover rate for Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group;
Time frame: 6 months
Immunogenic end points 3
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover were detected against the primary COVID-19 strain and Delta variant 14 days after vaccination in experimental group.
Time frame: 6 months
Immunogenic end points 4
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants 6 months after vaccination in the experimental group
Time frame: 6 months
Immunogenic end points 5
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants were detected 14 days after vaccination in the observation group
Time frame: 6 months
Immunogenic end points 6
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants in the observation group for 6 months
Time frame: 6 months
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