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History of Changes for Study: NCT04324606
A Study of a Candidate COVID-19 Vaccine (COV001)
Latest version (submitted April 8, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 26, 2020 None (earliest Version on record)
2 April 2, 2020 Arms and Interventions, Study Status, Eligibility and Oversight
3 April 14, 2020 Recruitment Status, Contacts/Locations and Study Status
4 April 17, 2020 Arms and Interventions, Study Description and Study Status
5 April 22, 2020 Arms and Interventions, Contacts/Locations, Eligibility, Outcome Measures, Study Design, Study Description and Study Status
6 May 7, 2020 Contacts/Locations, Arms and Interventions, Study Status, Eligibility, Outcome Measures and Study Design
7 May 15, 2020 Recruitment Status, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
8 May 22, 2020 Arms and Interventions and Study Status
9 July 6, 2020 Arms and Interventions, Outcome Measures and Study Status
10 August 17, 2020 Arms and Interventions, References, Eligibility, Outcome Measures and Study Status
11 September 30, 2020 Study Status, Outcome Measures, Study Description and Eligibility
12 October 29, 2020 Eligibility and Study Status
13 November 16, 2020 Outcome Measures and Study Status
14 March 22, 2021 Arms and Interventions, Outcome Measures and Study Status
15 April 8, 2021 Eligibility, Outcome Measures and Study Status
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Changes (Merged) for Study: NCT04324606
April 22, 2020 (v5) -- May 7, 2020 (v6)

Changes in: Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: COV001
Brief Title: A Study of a Candidate COVID-19 Vaccine (COV001)
Official Title: A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Recruiting
Study Start: April 23, 2020
Primary Completion: May 2021 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: March 20, 2020
First Submitted that
Met QC Criteria:
March 26, 2020
First Posted: March 27, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 22 May 7, 2020
Last Update Posted: April 24 May 8, 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 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).
Detailed Description: There will be 4 study groups and it is anticipated that a total of 1112 volunteers will be enrolled. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit at Day 364.
Open or close this module Conditions
Conditions: Coronavirus
Keywords: COVID-19, Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 7 9
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 1112 1090 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. 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 1b
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
Standard single dose of MenACWY vaccine delivered intramuscularly
Experimental: Group 2a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. 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 2b
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
Standard single dose of MenACWY vaccine delivered intramuscularly
Experimental: Group 3
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 2.5x10^10vp ChAdOx1 nCoV-19 at week 4.
Biological: ChAdOx1 nCoV-19 boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10^10vp of ChAdOx1 nCoV-19
Experimental: Group 4a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. 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 4b
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
Standard single dose of MenACWY vaccine delivered intramuscularly
Experimental: Group 4c
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 plus Paracetamol. 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
Drug: Paracetamol
1g every 6 hours for 24 hours
Active Comparator: Group 4d
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly plus Paracetamol. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
Drug: Paracetamol
1g every 6 hours for 24 hours
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases
Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

[Time Frame: 6 months]
2. Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) throughout the study duration

[Time Frame: 6 months]
Secondary Outcome Measures:
3. 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]
4. 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]
5. 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

[Time Frame: 28 days following vaccination]
6. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests
Change from baseline for safety laboratory measures (haematology and biochemistry blood results)

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

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

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

[Time Frame: 6 months]
11. 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]
12. 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]
13. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

[Time Frame: 6 months]
Other Pre-specified Outcome Measures:
14. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays
Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

[Time Frame: 6 months]
15. To assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol
All safety, reactogenicity, immunogenicity and efficacy endpoints

[Time Frame: 6 months]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria

The volunteer must satisfy all the following criteria to be eligible for the study:

  • Healthy adults aged 18-55 years.
  • Able and willing (in the Investigator's opinion) to comply with all study requirements (participants must not rely on public transport or taxis).
  • 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 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.

Exclusion Criteria

The volunteer may not enter the study if any of the following apply:

  • 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 use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days) .
  • Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
  • History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenACWY vaccines.
  • Any history of angioedema .
  • Any history of anaphylaxis .
  • Pregnancy, lactation or willingness/intention to become pregnant during the study.
  • History of 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 (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
  • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Any other serious chronic illness requiring hospital specialist supervision.
  • Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
  • Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine)
  • Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2)
  • 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 clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.
  • 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 or anosmia/ageusia since February 2020. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment.
  • 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. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment.
  • Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per PHE guidance)

Additional exclusion criteria (subset of participants receiving Paracetamol in group 4 only)

• History of allergic disease or reactions likely to be exacerbated by Paracetamol

Re-vaccination exclusion criteria

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
Open or close this module Contacts/Locations
Central Contact Person: Volunteer Recruitment Co-ordinator
Telephone: 01865 611424
Email: vaccinetrials@ndm.ox.ac.uk
Study Officials: Andrew Pollard, Prof
Principal Investigator
University of Oxford
Locations: United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
[ Not yet Recruiting]
Bristol, United Kingdom, BS1 3NU
Contact:Contact: Rajeka Lazarus
Imperial College Healthcare NHS Trust
[ Not yet Recruiting]
London, United Kingdom, W2 1NY
CCVTM, University of Oxford, Churchill Hospital
[Recruiting]
Oxford, United Kingdom, OX3 7LE
Contact:Contact: Volunteer Recruitment Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk
John Radcliffe Hospital
[Not yet recruiting]
Oxford, United Kingdom, OX3 9DU
United Kingdom, Hampshire
NIHR WTCRF, University Hospital Southampton NHS Foundation Trust
[ Not yet Recruiting]
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact:Contact: Study Coodinator UHS. southamptonCRF RecruitmentCRF@nhs.net
Contact:Principal Investigator: Saul Faust, PhD
United Kingdom, Tooting
St Georges University Hospital NHS Foundation Trust
[ Not yet Recruiting]
London, Tooting, United Kingdom, SW17 0QT
Contact:Contact: Katie Isitt cisitt@sgul.ac.uk
Contact:Principal Investigator: Paul Heath, Prof
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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