This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above. The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine . The immunization schedule is two doses intramuscular injections (deltoid).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
480
Intramuscular other name:Ad5-nCoV
Intramuscular other name:Ad5-nCoV
Taixing City center for Disease Control and Prevention
Taizhou, Jiangsu, China
Safety indexes of adverse reactions
Occurrence of adverse reactions post vaccination
Time frame: within 14 days post each vaccination
Immunogencity indexes of GMT
Evaluate the Geometric mean titer (GMT) of IgG antibody
Time frame: Day 28 post the second vaccination
Immunogencity indexes of neutralizing antibody
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Time frame: Day 28 post the second vaccination
Safety indexes of adverse events
Occurrence of adverse reactions post-vaccination
Time frame: Day 0-7,0-14,0-28 post each vaccination
Safety indexes of Hematological examination measures(Hemoglobin, WBC)
Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Time frame: pre-vaccination, day 4 post each vaccination
Safety indexes of Blood routine measures(ALT, AST)
Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Time frame: pre-vaccination, day 4 post each vaccination
Safety indexes of SAE
Occurrence of serious adverse events post-vaccination
Time frame: Within 6 months post the second vaccination
Immunogencity indexes of GMT
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Evaluate the Geometric mean titer of IgG antibody
Time frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Immunogencity indexes of neutralizing antibody
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Time frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Immunogencity indexes of cellular immune
Number of cell-mediated immune response against SARS-CoV-2(IL-2)
Time frame: Day 28 post the first vaccination, pre and day 28 post the second vaccination