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A Study of a Candidate COVID-19 Vaccine (COV003)

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ClinicalTrials.gov Identifier: NCT04536051
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE September 1, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE June 2, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR [ Time Frame: 12 months post final vaccination ]
COVID-19 virologically confirmed symptomatic cases (PCR positive).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination [ Time Frame: 7 days post vaccination ]
    Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)
  • Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events [ Time Frame: 12 months post final vaccination ]
    Occurrence of serious adverse events
  • Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease [ Time Frame: 12 months post final vaccination ]
    Occurrence of episodes; intensified disease
  • Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR [ Time Frame: 12 months post final vaccination ]
    Hospitalization for COVID-19 disease confirmed by PCR
  • Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR [ Time Frame: 12 months post final vaccination ]
    COVID-19 serious disease confirmed by PCR
  • Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease [ Time Frame: 6 months ]
    Death associated with COVID-19 disease
  • Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates) [ Time Frame: 12 months post final vaccination ]
    Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).
  • Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates) [ Time Frame: 12 months post final vaccination ]
    Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)
  • Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus [ Time Frame: 12 months post final vaccination ]
    Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus
  • Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine [ Time Frame: 12 months post final vaccination ]
    Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Candidate COVID-19 Vaccine (COV003)
Official Title  ICMJE A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine
Brief Summary A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.
Detailed Description

There will be 2 study groups and an anticipated enrolment of 10,300 health professionals and adults with high potential for exposure to SARS-CoV-2, aged ≥18 years.

All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Coronavirus
Intervention  ICMJE
  • Biological: ChAdOx1 nCoV-19 single dose + paracetamol
    Single dose of ChAdOx1nCOV19 vaccine, 5x10^10 vp + paracetamol
  • Biological: MenACWY single dose + paracetamol
    Single dose of MenACWY + paracetamol
  • Biological: ChAdOx1 nCoV-19 two dose + paracetamol
    Two dose of ChAdOx1 nCoV-19 vaccine, 5x10^10vp (prime) and 0.5mL boost (3.5 - 6.5 × 10^10 vp), 4-12 weeks apart + paracetamol
  • Biological: MenACWY prime & saline placebo boost + paracetamol
    MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol
Study Arms  ICMJE
  • Experimental: Group 1a: single dose ChAdOx & paracetamol
    Participants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol
    Intervention: Biological: ChAdOx1 nCoV-19 single dose + paracetamol
  • Active Comparator: Group 1b: single dose MenACWY & paracetamol
    Participants will receive a single dose of MenACWY plus paracetamol
    Intervention: Biological: MenACWY single dose + paracetamol
  • Experimental: Group 1c: two dose ChAdOx & paracetamol
    Participants will receive two standard doses of ChAdOx1 nCoV-19 vaccine, 4-12 weeks apart, plus paracetamol
    Intervention: Biological: ChAdOx1 nCoV-19 two dose + paracetamol
  • Active Comparator: Group 1d: two dose MenACWy/saline & paracetamol
    Participants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol
    Intervention: Biological: MenACWY prime & saline placebo boost + paracetamol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
10300
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
5000
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults from 18 to 55 years of age
  • Adults aged 56-69 years old (after review of safety data by DSMB in this age group in the UK trial)
  • Adults aged 70 and above years old (after review of safety data by DSMB in this age group in the UK trial)
  • Able and willing (in the Investigator's opinion) to fulfill all study requirements;
  • Health professionals and adults at high risk of exposure to SARS-CoV-2, as defined in section 5.2 of this protocol;
  • Serology with SARS-CoV-2 negative IgG antibodies; This inclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards.
  • Willing to allow investigators to discuss the participant's clinical history with their GP/personal physician and access medical records relevant to the study procedures
  • Only for women of childbearing age willing to practice continuous effective birth control (see below) during the study, and a negative pregnancy test on the screening and vaccination day(s);
  • Consent to abstain from blood donation during the course of the study;
  • Provide informed consent in writing

Exclusion Criteria:

  • Participation in trials of prophylactic drugs for COVID-19 during the course of the study; Note: Participation in COVID-19 treatment trials is permitted in case of hospitalization due to COVID-19, after confirmation of positive PCR. The study team should be informed as soon as possible. Participants with COVID-19 not hospitalized with positive PCR results for COVID-19 may be medicated according to standard clinical practice.
  • Participation in SARS-CoV-2 serological research where participants are informed of their serological status during the course of the study;
  • Planned receipt of any vaccine (authorized or investigational), within 30 days before and after vaccination;
  • Prior receipt of an investigational vaccine or authorized with the possibility of impacting the interpretation of the study data (for example, vaccines vectorized by Adenovirus, any vaccines against coronavirus);
  • Administration of immunoglobulins and/or any blood products in the three months prior to the planned administration of the candidate vaccine;
  • Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
  • History of allergic disease or reactions possibly exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY or paracetamol;
  • Any history of angioedema;
  • Any history of anaphylaxis;
  • Pregnancy, lactation or willingness/intention to become pregnant during the study;
  • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
  • History of severe psychiatric illness that possibly affects your participation in the study;
  • Hemorrhagic disorder (for example, factor deficiency, coagulopathy or platelet disorder), or a previous history of significant bleeding or bruising after IM injections or venipuncture;
  • Current suspected or known dependence on alcohol or drugs;
  • Severe and/or uncontrolled cardiovascular diseases, respiratory diseases, gastrointestinal diseases, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are allowed);
  • History of COVID-19 confirmed by laboratory;
  • Seropositive for antibodies to SARS-CoV-2 before recruitment; This exclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards
  • Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
  • Any other significant illness, disorder or finding that may significantly increase the risk for the participant, affect his/her ability to participate in the study or impair the interpretation of the study data.

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

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Volunteer Recruitment Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04536051
Other Study ID Numbers  ICMJE COV003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Pollard, Prof University of Oxford
PRS Account University of Oxford
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP