A Study of a Candidate COVID-19 Vaccine (COV001)
- Conditions
- Coronavirus
- Interventions
- Biological: ChAdOx1 nCoV-19Biological: MenACWYBiological: ChAdOx1 nCoV-19 full boostBiological: ChAdOx1 nCoV-19 half boostBiological: MenACWY boostBiological: ChAdOx1 nCoV-19 0.5mL boostBiological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT)
- Registration Number
- NCT04324606
- Lead Sponsor
- University of Oxford
- Brief Summary
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
- Detailed Description
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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1090
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1a ChAdOx1 nCoV-19 Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 Group 1b MenACWY Volunteers will receive a standard single dose of MenACWY vaccine Group 1c ChAdOx1 nCoV-19 Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 5x10\^10vp ChAdOx1 nCoV-19 9 months later Group 1c ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 5x10\^10vp ChAdOx1 nCoV-19 9 months later Group 1d MenACWY Volunteers will receive a standard single dose of MenACWY vaccine. 9 moths later they will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 4-12 weeks apart Group 1d ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) Volunteers will receive a standard single dose of MenACWY vaccine. 9 moths later they will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 4-12 weeks apart Group 2a ChAdOx1 nCoV-19 Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 Group 2b MenACWY Volunteers will receive a standard single dose of MenACWY vaccine Group 2c ChAdOx1 nCoV-19 full boost Volunteers will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and week 8 Group 2d ChAdOx1 nCoV-19 half boost Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 2.5x10\^10vp ChAdOx1 nCoV-19 at week 8 Group 2e MenACWY boost Volunteers will receive two standard single doses of MenACWY vaccine at week 0 and week 8 Group 2f ChAdOx1 nCoV-19 0.5mL boost Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later Group 2g MenACWY boost Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart Group 3a ChAdOx1 nCoV-19 full boost Volunteers will receive one dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 4 Group 3b ChAdOx1 nCoV-19 full boost Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0, a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months Group 3b ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0, a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months Group 4a ChAdOx1 nCoV-19 Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 Group 4a Paracetamol Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 Group 4b MenACWY Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 delivered intramuscularly Group 4c ChAdOx1 nCoV-19 Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later Group 4c ChAdOx1 nCoV-19 0.5mL boost Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later Group 4d MenACWY boost Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart Group 5a ChAdOx1 nCoV-19 full boost Volunteers will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 ≤ 16 weeks apart, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months Group 5a ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) Volunteers will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 ≤ 16 weeks apart, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months Group 5b MenACWY boost Volunteers will receive two standard single doses of MenACWY vaccine ≤ 16 weeks apart, a dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months then a second dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) 4-12 weeks later Group 5b ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) Volunteers will receive two standard single doses of MenACWY vaccine ≤ 16 weeks apart, a dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months then a second dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) 4-12 weeks later Group 4b Paracetamol Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 delivered intramuscularly
- Primary Outcome Measures
Name Time Method Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases 6 months Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs) Throughout the study, average of 18 months 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
- Secondary Outcome Measures
Name Time Method Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) 7 or 28 days following vaccination Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (7 days following vaccination for groups 1c, 1d, 5a \& 5b)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests 6 months Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes 6 months Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions 6 months Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions 6 months Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths 6 months Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 6 months Occurrence of severe COVID-19 disease (defined according to clinical severity scales)
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates 6 months Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays 6 months Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 6 months Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Trial Locations
- Locations (6)
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
CCVTM, University of Oxford, Churchill Hospital
🇬🇧Oxford, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom