A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm
There will be 4 study groups and it is anticipated that a total of 1090 volunteers will be enrolled. Volunteers will participate in the study for approximately 12 months from last vaccination visit (approximately 15 months from enrolment for participants receiving 2 doses)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,077
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
Standard single dose of MenACWY vaccine delivered intramuscularly
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10\^10vp of ChAdOx1 nCoV-19
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Time frame: 6 months
Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) throughout the study until a cutoff date of 1st July 2021 or 6 months post late vaccination visit, whichever is latest
Time frame: Throughout the study, average of 18 months
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Time frame: 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Time frame: 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (7 days following vaccination for groups 1c, 1d, 5a \& 5b)
Time frame: 7 or 28 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests
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A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10\^10vp of ChAdOx1 nCoV-19
A standard dose of MenACWY followed by a boost dose of MenACWY
1g every 6 hours for 24 hours
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp)
A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp) 9 months after receiving a single or double dose of 5x10\^10vp of ChAdOx1 nCoV-19
A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp) 9 months after receiving a single or double dose of MenACWY, then a boost 4-12 weeks later
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Time frame: 6 months
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes
Occurrence of disease enhancement episodes
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions
Number of hospital admissions associated with COVID-19
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions
Number of intensive care unit admissions associated with COVID-19
Time frame: 6 months
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related 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
Occurrence of severe COVID-19 disease (defined according to clinical severity scales)
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 cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Time frame: 6 months
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Time frame: 6 months