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.
There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 \& 9 are adults aged 56-69 years; groups 2, 8 \& 10 are adults 70 years and over; groups 4, 5 \& 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults aged 18-55 years. The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm (preferably). All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
10,811
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Standard single dose of MenACWY vaccine
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10\^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Time frame: Study duration (12 months from last vaccination)
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults
Occurrence of serious adverse events (SAEs) throughout the study duration.
Time frame: Study duration (12 months from last vaccination)
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
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Time frame: 7 days post vaccination
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
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Time frame: 7 days post vaccination
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
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Time frame: 28 days post vaccination
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)
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Two standard doses of MenACWY vaccine 4-6 weeks apart
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by qPCR
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10\^10 vp Abs 260)
Two standard doses of MenACWY vaccine minimum 4 weeks apart
Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10\^11 vp/mL), 4-6 weeks apart
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10\^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Castle Hill Hospital
Cottingham, Hull, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, Tooting, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
NIHR Cambridge Clinical Research Facility
Cambridge, United Kingdom
NHS Lothian, Western General Hospital
Edinburgh, United Kingdom
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
Glasgow, United Kingdom
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
Liverpool, United Kingdom
...and 10 more locations
Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 \& 10)
Time frame: 6 months
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
Occurrence of disease enhancement episodes
Time frame: Study duration (12 months from last vaccination)
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
Number of hospital admissions associated with COVID-19
Time frame: Study duration (12 months from last vaccination)
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
Number of intensive care unit (ICU) admissions associated with COVID-19
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths
Number of deaths associated with COVID-19
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates
Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19
Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
Time frame: Study duration (12 months from last vaccination)
Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Time frame: 28 days post vaccination
Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Time frame: 28 days post vaccination
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only)
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Time frame: 6 months
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
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Time frame: 7 days post vaccination
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
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Time frame: 7 days post vaccination
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)
Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Time frame: 28 days post vaccination
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)
Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Time frame: 6 months
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
Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Time frame: 56 days post vaccination
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)
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Time frame: 56 days post vaccination