Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
Description: Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs)
Measure: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination
Measure: Solicited local and systemic adverse events (AEs) Time: 7 daysDescription: Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration
Measure: Unsolicited adverse events (AEs) Time: 21 daysDescription: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration
Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: 21 daysDescription: Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.
Measure: Safety labs Time: 3 daysDescription: Nab response induced by the vaccine against the SARS-CoV-2 virus
Measure: Neutralizing antibody (Nab assay) response Time: 21 daysDescription: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot)
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: 21 daysDescription: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: 21 daysDescription: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths from 22 days after the last vaccination up to the end of the study
Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: Day 42 to 386Description: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus, as measured by total IgG and/or IgM levels
Measure: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus measured by total IgG and/or IgM levels Time: Day 21, 42, 201 and 386Description: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus
Measure: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus Time: Day 201 and 386Description: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IFN- γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Day 201 and 386Description: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IL-4 ELISpot.
Measure: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Days 201 and 386Description: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by the percentage of CD4+ T cells expressing functional markers
Measure: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Day 21, 201 and 386Description: Specific antibody response induced by the vaccine against plant glycans as measured by serum IgE levels directed against Cross-reactive Carbohydrate Determinants (CCD) MUXF3 using bromelain glycoprotein
Measure: Specific antibody response induced by the vaccine against plant glycans Time: Day 21, 201 and 386Description: If deemed necessary, further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine
Measure: Further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine Time: Day 21, 42, 201, 386Description: Occurrence(s) of laboratory-confirmed (virologic or serologic methods) SARS-CoV-2 infection (with or without symptoms
Measure: Laboratory-confirmed SARS-CoV-2 infection Time: Day 0 to 386Description: • If deemed necessary, further characterization of the immune response of the Coronavirus-Like Particle COVID-19 Vaccine.
Measure: Characterization of the immune response of the Coronavirus-Like Particle COVID-19 Vaccine Time: Up to day 386Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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