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History of Changes for Study: NCT04324606
A Study of a Candidate COVID-19 Vaccine (COV001)
Latest version (submitted November 16, 2020) 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
Comparison Format:

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Changes (Merged) for Study: NCT04324606
March 26, 2020 (v1) -- August 17, 2020 (v10)

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

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:
Study Status
Record Verification: March 2020
Overall Status: Active, not yet recruiting
Study Start: March 2020 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:
March 26, 2020 August 17, 2020
Last Update Posted: March 27 August 19, 2020 [Actual]
Sponsor/Collaborators
Sponsor: University of Oxford
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
Brief Summary: A phase I/II single-blinded, randomised, placebo controlled, 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 5 4 study groups and it is anticipated that a total of 510 1090 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.
Conditions
Conditions: Coronavirus
Keywords: COVID-19, Vaccine
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 5 14
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 510 [Anticipated] 1090 [Actual]
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 placebo. delivered intramuscularly
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Placebo Active Comparator: Group 1b
Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo. Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly
Biological
Saline Placebo MenACWY
Saline injection delivered intramuscularly 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 placebo. delivered intramuscularly
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Placebo Active Comparator: Group 2b
Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo. Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly
Biological
Saline Placebo MenACWY
Saline injection delivered intramuscularly Standard single dose of MenACWY vaccine delivered intramuscularly
Experimental: Group 2c
Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly at week 0 and week 8
Biological: ChAdOx1 nCoV-19 full boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10^10vp of ChAdOx1 nCoV-19
Experimental: Group 2d
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 delivered intramuscularly
Biological: ChAdOx1 nCoV-19 half boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10^10vp of ChAdOx1 nCoV-19
Active Comparator: Group 2e
Volunteers will receive two standard single doses of MenACWY vaccine delivered intramuscularly at week 0 and week 8
Biological: MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Experimental: Group 2f
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, delivered intramuscularly
Biological: ChAdOx1 nCoV-19 0.5mL boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp)
Active Comparator: Group 2g
Volunteers will receive two standard single doses of MenACWY vaccine delivered intramuscularly a minimum of 4 weeks apart
Biological: MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Experimental: Group 3
Volunteers will receive two 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
Biological: ChAdOx1 nCoV-19
5x10^10vp of ChAdOx1 nCoV-19
Biological: ChAdOx1 nCoV-19 full boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10^10vp of ChAdOx1 nCoV-19
Experimental: Group 4a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly
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 4b
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly
Biological: MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
Drug: Paracetamol
1g every 6 hours for 24 hours
Experimental: Group 4c
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, delivered intramuscularly
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
Biological: ChAdOx1 nCoV-19 0.5mL boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp)
Active Comparator: Group 4d
Volunteers will receive two standard single doses of MenACWY vaccine delivered intramuscularly a minimum of 4 weeks apart
Biological: MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
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
Enzyme-linked immunosorbent assay (ELISA) to 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. Assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol
All safety, reactogenicity, immunogenicity and efficacy endpoints

[Time Frame: 6 months]
16. Assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) post boost

[Time Frame: 6 months]
17. Compare viral shedding on stool samples of SARS-CoV-2 PCR positive individuals
Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 positivity

[Time Frame: 6 months]
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 .with the exception of the seasonal influenza vaccination. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
  • 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) of immunosuppressant medication within the past 6 months (inhaled and , except topical steroids are allowed 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 hereditary angioedema or idiopathic angioedema .
  • Any history of anaphylaxis in relation to vaccination .
  • 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).
  • 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.
  • 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 and a cough or shortness of breath in the 30 days preceding screening and/or enrolment 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 Public Health England 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:

The following AEs associated with any vaccine, or identified on or before the day of vaccination constitute absolute contraindications to further administration of an IMP to the volunteer in question. If any of these events occur during the study, the subject will not be eligible to receive a booster dose and will be followed up by the clinical team or their GP until resolution or stabilisation of the event:

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
  • Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results
Contacts/Locations
Central Contact: 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, Hampshire
NIHR WTCRF, University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
St Georges University Hospital NHS Foundation Trust
London, United Kingdom, SW17 0QT
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
IPDSharing
Plan to Share IPD:
References
Citations:
Links: Description: Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Available IPD/Information:

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