Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug3606 | Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki | 0.82 |
drug3607 | Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki | 0.82 |
drug3496 | Questionnaire : Preparedness for Caregiving Scale Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D040921 | Stress Disorders, Traumatic NIH | 0.10 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.09 |
D018352 | Coronavirus Infections NIH | 0.06 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 3 clinical trials
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
Description: The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site, vital signs, blood routine, blood biochemistry, and urine routine.
Measure: The number of adverse events after intramuscular injection Time: Up to one year after the last vaccinationDescription: All subjects The levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ levels before each vaccination, day 14 after the first vaccination, day 7 after the second vaccination, and 1 and 6 months after the entire vaccination. All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Positive rate of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG). All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Titer level and its multiplier than before exemption of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG).
Measure: Immunogenic end point Time: Within 6 months after the last dose of vaccinationA total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Description: Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination
Measure: Neutralizing antibody positive conversion rate Time: 30 days after inoculationDescription: GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people
Measure: Neutralizing antibody GMT, positive rate Time: 14 days after inoculationDescription: GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population
Measure: Neutralizing antibody GMT, positive conversion rate/positive rate Time: 14 days after inoculationDescription: Neutralizing antibody GMT 30 days after vaccination in pre-negative people
Measure: Neutralizing antibody GMT Time: 30 days after inoculationDescription: Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination
Measure: Neutralizing antibody GMT Time: 6th and 12th month after inoculationDescription: Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination
Measure: Neutralizing antibody GMI, positive rate Time: 6th and 12th month after inoculationDescription: Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination
Measure: IL-2, IL-4, IL-5, IL-6 and IFN-γ levels Time: 4th day and 12 months after inoculationDescription: Adverse events 30 days after the first dose of vaccine to the entire exemption
Measure: Adverse events Time: 30 days after inoculationDescription: Serious adverse events from day 0 after vaccination to 12 months after the entire immunization
Measure: Serious adverse event Time: 12 months after inoculationA randomized, double-blind, placebo-controlled international multicenter clinical trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.
Description: The number of any severity of COVID-9 cases 14 days after whole vaccination
Measure: The endpoint of efficacy study Time: 14 days to one year after whole vaccinationDescription: Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination
Measure: The endpoint of safety study Time: From the first dose of vaccination until 30 days after full course of vaccinationDescription: Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination
Measure: The endpoint of safety study Time: From the first dose of vaccination until 12 months after full course of vaccinationDescription: The number of severe and severity above COVID-19 cases 14 days after whole vaccination; The number of any severity of COVID-9 cases after first dose of vaccination; The number of COVID-19 cases of any severity in populations of different age group (18-59 years vs. 60 years and above) 14 days after whole vaccination.
Measure: The endpoint of efficacy study Time: Up to one year after the vaccinationDescription: The level of neutralizing antibody to SARS-COV-2 and IgG level of RBD protein binding antibody at 14 days and 6 months after full course of vaccination.
Measure: Endpoint of immunogenicity and immune persistence study Time: At 14 days and 6 months after full course of vaccinationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports