This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV \> 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Nebulized inhalation through the mouth
Nebulized inhalation through the mouth
Incidence of COVID-19 cases.
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
Time frame: Day 14 to 12 months post vaccination
Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)
Time frame: Within 12 months post vaccination
Incidence of COVID-19 cases
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
Time frame: Day 28 to 12 months post vaccination
Incidence of severe COVID-19 cases
Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection.
Time frame: Day 14 and Day 28 to 12 months post vaccination
Incidence of COVID-19 cases in different age groups
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease in participants between 18-59 years, and participants aged 60 years and above.
Time frame: Day 14 and Day 28 to 12 months post vaccination
Incidence of Adverse Reactions (ARs)
Incidence of ARs within 30 minutes post vaccination in the safety cohort.
Time frame: Within 30 minutes post vaccination
Incidence of Adverse Reactions (ARs)
Incidence of ARs within 14 days post vaccination in the safety cohort.
Time frame: Within 14 days post vaccination
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Incidence of Adverse Events (AEs)
Incidence of AEs within 28 days post vaccination in the safety cohort.
Time frame: Within 28 days post vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
Seroconversion rate of S-RBD IgG antibody post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
GMT of S-RBD IgG antibody post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
GMI of S-RBD IgG antibody post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Seroconversion rate of neutralizing antibodies post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
GMT of neutralizing antibodies post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
GMI of neutralizing antibodies post vaccination.
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination