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    SARS-Cov2 spike protein-specific CD4+ and CD8+ T-cells responses

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (3)


    Name (Synonyms) Correlation
    drug358 BBV152 Wiki 1.00
    drug770 ChulaCov19 mRNA vaccine Wiki 1.00
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.20
    D018352 Coronavirus Infections NIH 0.16

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 mRNA Vaccine in Healthy Adults

    This study is conducted in two phases. The first phase of the study will assess the safety, tolerability and reactivity to the COVID-19 vaccine (ChulaCov19 messenger ribonucleic acid) administered at various doses through the muscles among healthy adults and the elderlies (age 65-75 years) (total 96 participants). Phase 2 will proceed dependent upon the results from phase 1 of the study. The second phase of the study will assess whether the vaccine can activate the immune system or not (total 600 participants) among healthy adults and the elderlies.

    NCT04566276
    Conditions
    1. COVID-19 Vaccine
    2. Safety Issues
    Interventions
    1. Biological: ChulaCov19 mRNA vaccine

    Primary Outcomes

    Description: Frequency of Adverse Events

    Measure: Frequency of Adverse Events

    Time: up to Day 50

    Description: Grade of Adverse Events

    Measure: Grade of Adverse Events

    Time: up to Day 50

    Description: Frequency of solicited reportable local Adverse Events: pain at the injection site, redness, swelling, erythema

    Measure: Frequency of solicited reportable local Adverse Events

    Time: during a 7-day follow-up period post each vaccination

    Description: Grade of solicited reportable local Adverse Events: pain at the injection site, redness, swelling, erythema

    Measure: Grade of solicited reportable local Adverse Events

    Time: during a 7-day follow-up period post each vaccination

    Description: Frequency of solicited reportable systemic Adverse Events: fever, fatigue, chills, headache, myalgias, arthralgias, vomiting, diarrhoea, new or worsened muscle pain (myalgias), and new or worsened joint pain (arthralgias).

    Measure: Frequency of solicited reportable systemic Adverse Events

    Time: during a 7-day follow-up period post each vaccination

    Description: Grade of of solicited reportable systemic Adverse Events: fever, fatigue, chills, headache, myalgias, arthralgias, vomiting, diarrhoea, new or worsened muscle pain (myalgias), and new or worsened joint pain (arthralgias).

    Measure: Grade of of solicited reportable systemic Adverse Events

    Time: during a 7-day follow-up period post each vaccination

    Description: Frequency of Serious Adverse Events

    Measure: Frequency of Serious Adverse Events

    Time: up to Day 387

    Description: Frequency of Medically-Attended Adverse Events

    Measure: Frequency of Medically-Attended Adverse Events

    Time: up to Day 387

    Description: Frequency of New-Onset Chronic Medical Conditions

    Measure: Frequency of New-Onset Chronic Medical Conditions

    Time: up to Day 387

    Description: degrees Celsius

    Measure: Measurement of body temperature

    Time: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: per minute

    Measure: measurement of respiratory rate

    Time: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: beats per minute (BPM)

    Measure: measurement of pulse rate

    Time: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: millimeter of mercury (mmHg)

    Measure: measurement of systolic blood pressure (SBP)

    Time: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: millimeter of mercury (mmHg)

    Measure: measurement of diastolic blood pressure (DBP)

    Time: Day -42, Day 1, Day 2, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the head

    Measure: assess if there are any symptoms at the head

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the ears

    Measure: assess if there are any symptoms at the ears

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the nose

    Measure: assess if there are any symptoms at the nose

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the throat

    Measure: assess if there are any symptoms at the throat

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the lungs

    Measure: assess if there are any symptoms at the lungs

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the lymph nodes

    Measure: assess if there are any symptoms at the lymph nodes

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the heart

    Measure: assess if there are any symptoms at the heart

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the abdomen

    Measure: assess if there are any symptoms at the abdomen

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: assess if there are any symptoms at the skin

    Measure: assess if there are any symptoms at the skin

    Time: Day -42, Day 1, Day 8, Day 22, Day 29, Day 50, Day 112, Day 202, and Day 387

    Description: g/dl

    Measure: Measurement of haemoglobin (Hb)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Measure: Measurement of haematocrit (HCT)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^6 cells/ul

    Measure: Measurement of red blood cell (RBC)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Measurement of white blood cells (WBC)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: percentage

    Measure: Assess the percentage of neutrophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Assess the number of neutrophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: percentage

    Measure: Assess the percentage of lymphocytes

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Assess the number of lymphocytes

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: percentage

    Measure: Assess the percentage of eosinophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Assess the number of eosinophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: Percentage

    Measure: Assess the percentage of basophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Assess the number of basophil

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: percentage

    Measure: Assess the percentage of monocytes

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Assess the number of monocytes

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: 10^3 cells/ul

    Measure: Measurement of platelet

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/l

    Measure: Measurement of sodium

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/l

    Measure: Measurement of potassium

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/l

    Measure: Measurement of chloride

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/l

    Measure: Measurement of bicarbonate

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dL

    Measure: Measurement of blood urea nitrogen (BUN)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dl

    Measure: Measurement of creatinine

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: g/dL

    Measure: Assess total protein

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: g/dL

    Measure: Measurement of albumin

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: unit/Liter (U/L)

    Measure: Measurement of lipase

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/L

    Measure: Measurement of phosphorus

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: U/L

    Measure: Measurement of gamma-glutamyl transferase (GGT)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dL

    Measure: Measurement of glucose

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: U/L

    Measure: Measurement of creatinine phosphokinase (CPK)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mmol/L

    Measure: Measurement of calcium

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dL

    Measure: Measurement of uric acid

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dL

    Measure: Measurement of C-reactive protein (CRP)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: U/L

    Measure: Measurement of alanine transaminase (ALT)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: U/L

    Measure: Measurement of aspartate transaminase (AST)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: U/L

    Measure: Measurement of alkaline phosphatase (ALP)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: mg/dL

    Measure: Assess total bilirubin

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: ml/min/1-73m^2

    Measure: Assess estimated glomerular filtration rate (eGFR)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: second

    Measure: Measurement of prothrombin time (PT)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: second

    Measure: Measurement of partial thromboplastin time (PTT)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Description: ratio

    Measure: Measurement of international normalized ratio (INR)

    Time: Day -42, Day 1,Day 8, Day 22, Day 29, Day 50

    Secondary Outcomes

    Description: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels

    Measure: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels

    Time: at Day 29 (7 days after the second dose)

    Description: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels

    Measure: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels

    Time: At Day 29

    Description: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers

    Measure: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers

    Time: from baseline to Day 29

    Description: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels

    Measure: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels

    Time: at Day 29

    Description: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels

    Measure: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels

    Time: at Day 29

    Description: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers

    Measure: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers

    Time: from baseline to Day 29

    Description: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody

    Measure: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody

    Time: at Day 29

    Description: Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody

    Measure: Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody

    Time: from baseline to Day 29

    Description: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody

    Measure: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody

    Time: from baseline to Day 29

    Description: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses

    Measure: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses

    Time: Day 29

    Description: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses

    Measure: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses

    Time: Day 29

    Description: Median number of spot-forming cells (SFC) per 1 million PBMCs

    Measure: Median number of spot-forming cells (SFC) per 1 million PBMCs

    Time: Day 29

    Description: Percentage of participants who shows positive specific Th1 responses

    Measure: Percentage of participants who shows positive specific Th1 responses

    Time: Day 29

    Description: Percentage of participants who shows positive specific Th2 responses

    Measure: Percentage of participants who shows positive specific Th2 responses

    Time: Day 29

    Description: Median percentage specific Th1 responses

    Measure: Median percentage specific Th1 responses

    Time: Day 29

    Description: Median percentage specific Th2 responses

    Measure: Median percentage specific Th2 responses

    Time: Day 29

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    Data processed on January 01, 2021.

    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.

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    MeSH

    706 reports on MeSH terms

    HPO

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