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ChAdox1 n-CoV vaccine low doseWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug300 ChAdOx1 nCoV-19 + boost Wiki 1.00
drug816 MenACWY vaccine + boost Wiki 1.00
drug815 MenACWY vaccine Wiki 1.00
drug299 ChAdOx1 nCoV-19 Wiki 0.71

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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 Coronavirus Biological: ChAdOx1 nCoV-19 Biological: MenACWY vaccine Biological: ChAdOx1 nCoV-19 + boost Biological: MenACWY vaccine + boost Biological: ChAdox1 n-CoV vaccine low dose
MeSH:Coronavirus Infections

Primary Outcomes

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 months

Description: 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 months

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)

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: 6 months

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: 6 months

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: 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 and 3 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 and 2 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: 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

No related HPO nodes (Using clinical trials)