This is an open-label, randomized, parallel-controlled clinical trial conducted in people aged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2 bivalent vaccines constructed by adenovirus type 5-based or mRNA-based technics.
The clinical trial plans to recruit 450 subjects aged 18 years and above with an interval of ≥ 3 months between the previous dose of SARS-CoV-2 vaccine immunization and receive one dose of inhaled prototype strain and omicron BA.4/5 bivalent recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-NCO5T-IH), beta strain and omicron BA.4/5 bivalent SARS-CoV-2 mRNA vaccine (mbO5) or inhaled prototype recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-nCoV-IH) for follow-up until 6 months after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
450
Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively
Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively
Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGAnti-XBB-specific neutralizing antibody
GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination
Time frame: on day 28 post vaccination
The incidence of adverse reactions
The incidence of adverse reactions within 28 days post vaccination
Time frame: within 28 days post vaccination
The incidence of adverse reactions
The incidence of adverse reactions within 30 mins post vaccination
Time frame: within 30 mins post vaccination
The incidence of adverse event
The incidence of adverse event within 28 days post vaccination
Time frame: within 28 days post vaccination
The incidence of SAE and AESI
The incidence of SAE and AESI within 6 months post vaccination
Time frame: within 6 months post vaccination
specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
The positive conversion rate, GMT and GMI of specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
Time frame: on 0, 28 days post vaccination
specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months
The positive conversion rate, GMT and GMI of specific neutralizing antibody against XBB and BA.5 variant from first 90 subjects at 14 days, 3 and 6 months
Time frame: at 14 days, 3 and 6 months
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