This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
508
Intramuscular injection
Intramuscular injection
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Occurrence of adverse reactions
Time frame: 0-14 days post vaccination
Anti SARS-CoV-2 S IgG antibody response(ELISA)
Time frame: 28 days post vaccination
Neutralizing antibody response to SARS-CoV-2
Time frame: 28 days post vaccination
Occurrence of adverse events
Time frame: 0-28 days post vaccination
Occurrence of serious adverse reaction
Time frame: 0-6 months post vaccination
Anti SARS-CoV-2 S IgG antibody response(ELISA)
Time frame: 0, 14 days and 6 months post vaccination
Neutralizing antibody response to SARS-CoV-2
Time frame: 0 and 6 months post vaccination
Neutralizing antibody response to Ad5-vector
Time frame: 0, 28 days and 6 months post vaccination
IFN-γ ELISpot responses to SARS-CoV-2 spike protein
Time frame: 0 and 28 days post vaccination
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