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Trial record 1 of 2 for:    COV002
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Investigating a Vaccine Against COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400838
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: ChAdOx1 nCoV-19 Biological: MenACWY vaccine Biological: ChAdOx1 nCoV-19 + boost Biological: MenACWY vaccine + boost Biological: ChAdox1 n-CoV vaccine low dose Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10260 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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



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:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT04400838


Contacts
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Contact: Volunteer Recruitment Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk

Locations
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Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Andrew Pollard, Prof University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04400838    
Other Study ID Numbers: COV002
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 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
ChAdOx1 nCov19
sars-cov-2
vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs