This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
840
Jiangsu Provincal Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Incidence of Adverse Reactions (AR)
The occurrence of Adverse Reactions (AR) in all groups
Time frame: 0-14 days after each vaccination
Incidence of Serious Adverse Events (SAE)
The occurrence of Serious Adverse Events (SAE) in all groups
Time frame: Within the first and final vaccination up until 12 months after the final vaccination
Incidence of Adverse Events/Reactions (AE/AR)
The occurence of Adverse Events/Reactions (AE/AR) in all groups
Time frame: Within 0-7 days after each vaccination
Incidence of Adverse Events/Reactions (AE/AR)
The occurence of Adverse Events/Reactions (AE/AR) in all groups
Time frame: Within 0-28 days after each vaccination
Changes in laboratory test indicators
Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups
Time frame: 4 days after each vaccination
GMT of Covid-19 S protein RBD specific antibody
GMT of S protein RBD specific antibody by ELISA
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Seroconversion rate of Covid-19 S protein RBD specific antibody
Seroconversion rate of S protein RBD specific antibody by ELISA
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
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Intramuscular administration
GMI of Covid-19 S protein RBD specific antibody
GMI of S protein RBD specific antibody by ELISA
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
GMT of SARS-CoV-2 neutralizing antibody against pseudovirus
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMI of SARS-CoV-2 neutralizing antibody
GMI of SARS-CoV-2 neutralizing antibody against pseudovirus
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after the final vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after the final vaccination
Cellular immune response
The positive rate of IFN-γ stimulated by S protein ELISpot
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of TNF-α stimulated by S protein ELISpot
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-5 stimulated by S protein ELISpot
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-4 stimulated by S protein ELISpot
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-13 stimulated by S protein ELISpot
Time frame: Before the first dose, 14 days after the first dose