Covid 19 Research using Clinical Trials (Home Page)
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Wiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014777 | Virus Diseases NIH | 0.11 |
| D007239 | Infection NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.07 |
| D018352 | Coronavirus Infections NIH | 0.06 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
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) .
NCT04313127 COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Primary Outcomes
Description: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse reactions Time: 0-7 days post-vaccinationSecondary Outcomes
Description: Occurrence of adverse events post-vaccination
Measure: Safety indexes of adverse events Time: 0-28 days post-vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: 0-28 days, within 6 mouths post-vaccinationDescription: Occurrence of abnormal changes of laboratory safety examinations
Measure: Safety indexes of lab measures Time: pre-vaccination, day 7 post-vaccinationDescription: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMT(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of seropositivity rates(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMI(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMC(Ad5 vector) Time: day、14,28，month3,6 post-vaccinationDescription: Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMI(Ad5 vector) Time: day、14,28，month3,6 post-vaccinationDescription: specific cellular immune responses
Measure: Immunogencity indexes of cellular immune Time: day 14, 28,month 6 post-vaccinationOther Outcomes
Description: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method
Measure: Consistency analysis(ELISA and pseudoviral neutralization test method) Time: day,14,28, month 6 post-vaccinationDescription: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship（Humoral immunity） Time: day14,28，month 3,6 post-vaccinationDescription: Persistence analysis of anti-S protein antibodies among study groups
Measure: Persistence analysis of anti-S protein antibodies Time: day14,28，month 3,6 post-vaccinationDescription: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship（Humoral immunity） Time: day14,28，month 3,6 post-vaccinationDescription: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship（ cellular immunity） Time: day 14, 28,month 6 post-vaccinationDescription: Persistence analysis of specific cellular immune response
Measure: Persistence analysis of cellular immuse Time: day 14, 28,month 6 post-vaccinationDescription: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship（cellular immunity） Time: day 14, 28,month 6 post-vaccination