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    ChAdOx1 nCov19

    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 (17)


    Name (Synonyms) Correlation
    drug3499 Two dose MenACWY vaccine min. 4 weeks apart Wiki 0.71
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.71
    drug2002 MenACWY single dose + paracetamol Wiki 0.71
    Name (Synonyms) Correlation
    drug740 ChAdOx1 nCoV-19 two dose + paracetamol Wiki 0.71
    drug3497 Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki 0.71
    drug2003 MenACWY vaccine Wiki 0.71
    drug364 BCG Wiki 0.71
    drug736 ChAdOx1 nCoV-19 0.5mL prime plus boost Wiki 0.71
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.71
    drug3498 Two dose MenACWY vaccine Wiki 0.71
    drug734 ChAdOx1 nCoV-19 (qPCR) Wiki 0.71
    drug733 ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki 0.71
    drug732 ChAdOx1 nCoV-19 (Abs 260) Wiki 0.71
    drug3496 Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki 0.71
    drug384 BNT162b1 Wiki 0.41
    drug385 BNT162b2 Wiki 0.35
    drug2490 Placebo Wiki 0.18

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.23

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials


    1 A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine

    A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.

    NCT04536051
    Conditions
    1. Coronavirus
    Interventions
    1. Biological: ChAdOx1 nCoV-19 single dose + paracetamol
    2. Biological: MenACWY single dose + paracetamol
    3. Biological: ChAdOx1 nCoV-19 two dose + paracetamol
    4. Biological: MenACWY prime & saline placebo boost + paracetamol
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: COVID-19 virologically confirmed symptomatic cases (PCR positive).

    Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR

    Time: 12 months post final vaccination

    Secondary Outcomes

    Description: Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)

    Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination

    Time: 7 days post vaccination

    Description: Occurrence of serious adverse events

    Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events

    Time: 12 months post final vaccination

    Description: Occurrence of episodes; intensified disease

    Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease

    Time: 12 months post final vaccination

    Description: Hospitalization for COVID-19 disease confirmed by PCR

    Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR

    Time: 12 months post final vaccination

    Description: COVID-19 serious disease confirmed by PCR

    Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR

    Time: 12 months post final vaccination

    Description: Death associated with COVID-19 disease

    Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease

    Time: 6 months

    Description: Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).

    Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates)

    Time: 12 months post final vaccination

    Description: Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)

    Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates)

    Time: 12 months post final vaccination

    Description: Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus

    Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus

    Time: 12 months post final vaccination

    Description: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

    Measure: Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine

    Time: 12 months post final vaccination
    2 A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19

    A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.

    NCT04400838
    Conditions
    1. Coronavirus
    Interventions
    1. Biological: ChAdOx1 nCoV-19 (Abs 260)
    2. Biological: MenACWY vaccine
    3. Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
    4. Biological: Two dose MenACWY vaccine
    5. Biological: ChAdOx1 nCoV-19 (qPCR)
    6. Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
    7. Biological: Two dose MenACWY vaccine min. 4 weeks apart
    8. Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.5mL
    9. Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19

    Measure: Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.

    Time: Study duration (12 months from last vaccination)

    Description: Occurrence of serious adverse events (SAEs) throughout the study duration.

    Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults

    Time: Study duration (12 months from last vaccination)

    Secondary Outcomes

    Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

    Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following

    Time: 7 days post vaccination

    Description: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

    Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following

    Time: 7 days post vaccination

    Description: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

    Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

    Time: 28 days post vaccination

    Description: Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 & 10)

    Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests)

    Time: 6 months

    Description: Occurrence of disease enhancement episodes

    Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes

    Time: Study duration (12 months from last vaccination)

    Description: Number of hospital admissions associated with COVID-19

    Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions

    Time: Study duration (12 months from last vaccination)

    Description: Number of intensive care unit (ICU) admissions associated with COVID-19

    Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

    Time: 6 months

    Description: Number of deaths associated with COVID-19

    Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths

    Time: 6 months

    Description: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

    Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates

    Time: 6 months

    Description: Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)

    Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19

    Time: Study duration (12 months from last vaccination)

    Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

    Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification

    Time: 28 days post vaccination

    Description: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination

    Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion

    Time: 28 days post vaccination

    Description: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

    Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only)

    Time: 6 months

    Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity

    Time: 7 days post vaccination

    Description: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity

    Time: 7 days post vaccination

    Description: Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)

    Time: 28 days post vaccination

    Description: Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests)

    Time: 6 months

    Description: Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion

    Time: 56 days post vaccination

    Description: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination

    Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)

    Time: 56 days post vaccination

    Other Outcomes

    Description: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

    Measure: Exploratory Immunology by virus neutralising antibody assays

    Time: 6 months

    Description: Cell analysis by flow cytometry assays

    Measure: Exploratory Immunology by flow cytometry

    Time: 6 months

    Description: Functional antibody assays

    Measure: Exploratory Immunology by functional antibody assays

    Time: 6 months

    Description: Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19

    Measure: Exploratory Immunology: anti-vector immunity

    Time: 6 months

    Description: Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures

    Measure: Measure exposure to COVID-19

    Time: 6 months

    Description: Number of PCR or NAAT positive cases of COVID-19 infection

    Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection by PCR or NAAT

    Time: 6 months

    Description: Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections

    Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection

    Time: 6 months

    Description: Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).

    Measure: Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002

    Time: 6 months

    Description: Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B, C and D respectively (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).

    Measure: Compare safety, reactogenicity and immunogenicity between different methods for measuring doses

    Time: 6 months

    Description: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals

    Measure: Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals

    Time: 6 months

    Description: Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity

    Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals

    Time: 6 months

    Description: Differences in antibody titres (ELISA and Neutralising antibodies) in participants who received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)

    Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres

    Time: 6 months

    Description: Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19

    Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses

    Time: 6 months

    Description: Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.

    Measure: Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19

    Time: 6 months

    Description: Cell-mediated and humoral responses against SARS-Cov-2 These will be measured by the following: Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses Further exploratory immunology

    Measure: Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults

    Time: 6 months

    Description: Relationship between nadir CD4 count vs vaccine immune responses

    Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: CD4 count-vaccine immune responses

    Time: 6 months

    Description: Relationship between age at enrolment and vaccine immune response

    Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: age vs vaccine immune responses

    Time: 6 months

    Description: Immune responses to ChAdOx1 nCoV-19 (assessed as described above)

    Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults

    Time: 6 months

    Description: Measured by the following: Occurrence of serious adverse events (SAEs) throughout the study duration Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination Occurrence of unsolicited AEs for 28 days following each vaccination

    Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults

    Time: Study duration (12 months from last vaccination)

    Description: Change in Total HIV DNA copies per million CD4 T cells

    Measure: To assess Impact of vaccination on HIV reservoirs

    Time: Study duration (12 months from last vaccination)

    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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