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Trial record 1 of 5 for:    COV001
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A Study of a Candidate COVID-19 Vaccine (COV001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324606
Recruitment Status : Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Coronavirus Biological: ChAdOx1 nCoV-19 Biological: MenACWY Biological: ChAdOx1 nCoV-19 full boost Biological: ChAdOx1 nCoV-19 half boost Biological: MenACWY boost Drug: Paracetamol Biological: ChAdOx1 nCoV-19 0.5mL boost Phase 1 Phase 2

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 6 months, with the option to come for an additional follow up visit at Day 364.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1090 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1a
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

Active Comparator: Group 1b
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly
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 delivered intramuscularly
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
Biological: MenACWY
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 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 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




Primary Outcome Measures :
  1. Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases [ 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: Occurrence of serious adverse events (SAEs) [ 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: Occurrence of solicited local reactogenicity signs and symptoms [ Time Frame: 7 days following 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: Occurrence of solicited systemic reactogenicity signs and symptoms [ Time Frame: 7 days following 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: Occurrence of unsolicited adverse events (AEs) [ Time Frame: 28 days following 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 through standard blood tests [ Time Frame: 6 months ]
    Change 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 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 [ Time Frame: 6 months ]
    Number of deaths 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 hospital admissions associated with COVID-19

  8. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]
    Number of intensive care unit admissions 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 cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]
    Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

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


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

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

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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:

  • 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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324606


Locations
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United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
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
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
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Andrew Pollard, Prof University of Oxford
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04324606    
Other Study ID Numbers: COV001
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
COVID-19, Vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics