The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
This is a single-center,open-label,dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
108
Intramuscular other name:Ad5-nCoV
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Safety indexes of adverse reactions
Occurrence of adverse reactions post-vaccination
Time frame: 0-7 days post-vaccination
Safety indexes of adverse events
Occurrence of adverse events post-vaccination
Time frame: 0-28 days post-vaccination
Safety indexes of SAE
Occurrence of serious adverse events post-vaccination
Time frame: 0-28 days, within 6 mouths post-vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of laboratory safety examinations
Time frame: pre-vaccination, day 7 post-vaccination
Immunogencity indexes of GMT(ELISA)
Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Time frame: day14,28,month 3,6 post-vaccination
Immunogencity indexes of GMT(pseudoviral neutralization test method)
Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Time frame: day14,28,month 6 post-vaccination
Immunogencity indexes of seropositivity rates(ELISA)
the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Time frame: day14,28,month 3,6 post-vaccination
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)
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the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Time frame: day14,28,month 6 post-vaccination
Immunogencity indexes of GMI(ELISA)
Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Time frame: day14,28,month 3,6 post-vaccination
Immunogencity indexes of GMI(pseudoviral neutralization test method)
Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Time frame: day14,28,month 6 post-vaccination
Immunogencity indexes of GMC(Ad5 vector)
Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses
Time frame: day、14,28,month3,6 post-vaccination
Immunogencity indexes of GMI(Ad5 vector)
Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses
Time frame: day、14,28,month3,6 post-vaccination
Immunogencity indexes of cellular immune
specific cellular immune responses
Time frame: day 14, 28,month 6 post-vaccination