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ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boostWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (8)


Name (Synonyms) Correlation
drug549 ChAdox1 n-CoV-19 (Abs 260) vaccine low dose Wiki 1.00
drug2470 Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care. Wiki 1.00
drug1467 MenACWY vaccine Wiki 1.00
drug548 ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR) Wiki 1.00
drug2567 Two dose MenACWY vaccine Wiki 1.00
drug545 ChAdOx1 nCoV-19 (qPCR) Wiki 1.00
drug2568 Two dose MenACWY vaccine 4-12 weeks Wiki 1.00
drug543 ChAdOx1 nCoV-19 (Abs 260) Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

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 (Abs 260) Biological: MenACWY vaccine Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Biological: Two dose MenACWY vaccine Biological: ChAdox1 n-CoV-19 (Abs 260) vaccine low dose Biological: ChAdOx1 nCoV-19 (qPCR) Biological: ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR) Biological: Two dose MenACWY vaccine 4-12 weeks
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 (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 vaccination

Description: 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 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: 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 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 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 (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 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 positivity

Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR 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


No related HPO nodes (Using clinical trials)