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History of Changes for Study: NCT04400838
Investigating a Vaccine Against COVID-19
Latest version (submitted June 18, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2020 None (earliest Version on record)
2 June 29, 2020 Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
3 July 9, 2020 Study Description and Study Status
4 August 11, 2020 Arms and Interventions, Outcome Measures, Eligibility, Study Design, Study Description and Study Status
5 August 21, 2020 Eligibility and Study Status
6 October 12, 2020 Outcome Measures, Arms and Interventions, Eligibility, Study Design, Study Description and Study Status
7 October 22, 2020 Eligibility and Study Status
8 November 12, 2020 Study Status
9 November 16, 2020 Outcome Measures, Eligibility and Study Status
10 December 8, 2020 Arms and Interventions, Eligibility, Outcome Measures, Study Description and Study Status
11 April 19, 2021 Eligibility, Outcome Measures and Study Status
12 June 18, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Description
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Study NCT04400838
Submitted Date:  May 22, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: COV002
Brief Title: Investigating a Vaccine Against COVID-19
Official Title: A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: May 2020
Primary Completion: August 2021 [Anticipated]
Study Completion: August 2021 [Anticipated]
First Submitted: May 12, 2020
First Submitted that
Met QC Criteria:
May 22, 2020
First Posted: May 26, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 22, 2020
Last Update Posted: May 26, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oxford
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description: There will be 4 study groups and it is anticipated that a total of 10,260 volunteers will be enrolled. Groups 1 and 2 are adults over the age of 56 and will participate in the study for 6 months with the option to come for an additional follow up visit at day 364. Group 3 is children aged 5-12 years will participate in the study for 6 months with the option to come for an additional follow up visit at day 364. Group 4 is adults over the age of 18 and will participate in the study for 3 months with the option to come for an additional follow up visit at day 182.
Open or close this module Conditions
Conditions: Coronavirus
Keywords: Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Sequential Assignment
Number of Arms: 14
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 10260 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1aE
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 1aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 1bE
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 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 + boost
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 4 weeks apart
Active Comparator: Group 1bA
Volunteers will receive one dose of MenACWY at week 0 and one dose of MenACWY at week 4 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine + boost
Two standard doses of MenACWY vaccine 4 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 2aE
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 2aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 2bE
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 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 + boost
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 4 weeks apart
Active Comparator: Group 2bA
Volunteers will receive one dose of MenACWY at week 0 and one dose of MenACWY at week 4 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine + boost
Two standard doses of MenACWY vaccine 4 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 3E
Volunteers will receive a single dose of 2.5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdox1 n-CoV vaccine low dose
A single dose of 2.5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 3A
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 4E
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 4A
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 5E
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 5A
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
[ Time Frame: 6 months ]

Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children
[ Time Frame: 6 months ]

Occurrence of serious adverse events (SAEs) throughout the study duration.
Secondary Outcome Measures:
1. 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 Frame: 7 days post vaccination ]

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
2. 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 Frame: 7 days post vaccination ]

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
3. 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 Frame: 28 days post vaccination ]

Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
4. 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 Frame: 6 months ]

Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results)
5. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
[ Time Frame: 6 months ]

Occurrence of disease enhancement episodes
6. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
[ Time Frame: 6 months ]

Number of hospital admissions associated with COVID-19
7. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
[ Time Frame: 6 months ]

Number of intensive care unit (ICU) admissions associated with COVID-19
8. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths
[ Time Frame: 6 months ]

Number of deaths associated with COVID-19
9. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates
[ Time Frame: 6 months ]

Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
10. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
[ Time Frame: 28 days post vaccination ]

Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
11. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
[ Time Frame: 28 days post vaccination ]

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
12. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2 and 3 only)
[ Time Frame: 6 months ]

Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
13. 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 Frame: 7 days post vaccination ]

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
14. 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 Frame: 7 days post vaccination ]

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
15. 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 Frame: 28 days post vaccination ]

Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
16. 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 Frame: 6 months ]

Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
17. 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 Frame: 56 days post vaccination ]

Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
18. 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 Frame: 56 days post vaccination ]

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Other Outcome Measures:
1. Exploratory Immunology by virus neutralising antibody assays
[ Time Frame: 6 months ]

Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
2. Exploratory Immunology by flow cytometry
[ Time Frame: 6 months ]

Cell analysis by flow cytometry assays
3. Exploratory Immunology by functional antibody assays
[ Time Frame: 6 months ]

Functional antibody assays
4. Measure exposure to COVID-19
[ Time Frame: 6 months ]

Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Adults aged 18 or older (group 4)
  • Adults aged 56 or older (groups 1 and 2)
  • Children aged 5-12 inclusive (group 3)
  • Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
  • For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.
  • Parent/Guardian provides informed consent

Exclusion Criteria:

  • Current or planned participation in other clinical trial of an investigational medicinal product
  • Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment
  • Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
  • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed).
  • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
  • Any history of hereditary angioedema or idiopathic angioedema.
  • Any history of anaphylaxis.
  • Pregnancy, lactation or willingness/intention to become pregnant during the study.
  • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious psychiatric condition likely to affect participation in the study.
  • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • History of laboratory confirmed COVID-19.
  • New onset of fever or a cough or shortness of breath since February 2020
  • Those who have been at high risk of exposure before enrolment, including but not limited to: close contacts of confirmed COVID-19 cases, anyone who had to self-isolate as a result of a symptomatic household member, frontline healthcare professionals working in A&E, ICU and other higher risk areas and significant exposure associated with travel abroad to high incidence areas since January 2020.
  • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Additional Exclusion criteria to Groups 1 and 2
  • Chronic respiratory disease, including asthma
  • Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild well controlled comorbidities are allowed)
  • Seriously overweight (BMI≥40 Kg/m2)
  • History of auto-immune disease

Additional Exclusion Criteria to Group 3

  • Chronic medical conditions such as chronic lung disease, chronic liver disease, chronic renal failure, chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21)
  • Fulfil any of the contraindications to vaccination as specified in The Green Book

Re-vaccination exclusion criteria (two-dose groups only)

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
Open or close this module Contacts/Locations
Central Contact Person: Volunteer Recruitment Coordinator
Telephone: 01865 611424
Email: vaccinetrials@ndm.ox.ac.uk
Study Officials: Andrew Pollard, Prof
Principal Investigator
University of Oxford
Locations: United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Contact:Contact: Christopher Green, PhD
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
North Bristol NHS Trust
Bristol, United Kingdom
Contact:Contact: Rajeka Lazarus, DPhil
NIHR Cambridge Clinical Research Facility
Cambridge, United Kingdom, CB2 0QQ
Contact:Contact: Estee Torok, PhD
Contact:Contact: Mark Toshner, PhD
Public Health Wales
Cardiff, United Kingdom, CF10 4BQ
Contact:Contact: James Adamson, DPH
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Contact:Contact: Patrick Lillie, PhD
NHS Lothian, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Contact:Contact: Rebecca Sutherland, MBChB
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
Glasgow, United Kingdom, G31 2ER
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
LIverpool, United Kingdom, L7 8XZ
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
London, United Kingdom, HA1 3UJ
Contact:Contact: Alistair McGregor, DTM&H
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
London, United Kingdom, SE1 7EH
Contact:Contact: Anna Goodman, DPhil
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
University of Nottingham Health Service, Cripps Health Centre, University Park
Nottingham, United Kingdom, NG7 2QW
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Contact:Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2RX
Contact:Contact: Thomas Darton, PhD
United Kingdom, Hampshire
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact:Contact: Study Coodinator UHS.RecruitmentCRF@nhs.net
Contact:Principal Investigator: Saul Faust, PhD
United Kingdom, Tooting
St Georges University Hospital NHS Foundation Trust
London, Tooting, United Kingdom, SW17 0QT
Open or close this module IPDSharing
Plan to Share IPD:
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Citations:
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Available IPD/Information:

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