Name (Synonyms) | Correlation | |
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drug2589 | Sensbiosys Wiki | 1.00 |
drug642 | ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR) Wiki | 1.00 |
drug638 | ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki | 1.00 |
drug637 | ChAdOx1 nCoV-19 (Abs 260) Wiki | 1.00 |
drug1723 | MenACWY vaccine Wiki | 1.00 |
drug639 | ChAdOx1 nCoV-19 (qPCR) Wiki | 1.00 |
drug643 | ChAdox1 n-CoV-19 (Abs 260) vaccine low dose Wiki | 1.00 |
drug2979 | Two dose MenACWY vaccine 4-12 weeks Wiki | 1.00 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
Description: Number of virologically confirmed (PCR 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: 6 monthsDescription: Occurrence of serious adverse events (SAEs) throughout the study duration.
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children Time: 6 monthsDescription: 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 vaccinationDescription: 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 vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (except groups 4 & 6)
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 vaccinationDescription: Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4 and 6)
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 monthsDescription: 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: 6 monthsDescription: 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: 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification Time: 28 days post vaccinationDescription: 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 vaccinationDescription: 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 and 3 only) Time: 6 monthsDescription: 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 and 2 only): local reactogenicity Time: 7 days post vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 monthsDescription: 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 vaccinationDescription: 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 vaccinationDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Exploratory Immunology by virus neutralising antibody assays Time: 6 monthsDescription: Cell analysis by flow cytometry assays
Measure: Exploratory Immunology by flow cytometry Time: 6 monthsDescription: Functional antibody assays
Measure: Exploratory Immunology by functional antibody assays Time: 6 monthsDescription: Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
Measure: Exploratory Immunology: anti-vector immunity Time: 6 monthsDescription: 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 monthsDescription: Number of PCR 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 Time: 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B/C (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 (Abs260, Abs260 corrected for PS80, and qPCR) of ChAdOx1 nCoV-19 Time: 6 monthsDescription: 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 monthsDescription: Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 positivity
Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR positive individuals Time: 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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