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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).
Number of adverse events after 2 doses given intramuscularly according to different immunization programs
The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.
Time frame: 6 months after 2 doses of vaccine
Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Immunogenic end points
Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Immunogenic end points
Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate.
Time frame: 6 months after 2 doses of vaccine
Laboratory markers of immunity
Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine.
Time frame: 6 months after 2 doses of vaccine
Immunogenic end points
Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.
Time frame: 6 months after 2 doses of vaccine
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