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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

Brief Summary:
A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: ChAdOx1 nCoV-19 single dose + paracetamol Biological: MenACWY single dose + paracetamol Biological: ChAdOx1 nCoV-19 two dose + paracetamol Biological: MenACWY prime & saline placebo boost + paracetamol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Group 1a: single dose ChAdOx & paracetamol
Participants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol
Biological: ChAdOx1 nCoV-19 single dose + paracetamol
Single dose of ChAdOx1nCOV19 vaccine, 5x10^10 vp + paracetamol

Active Comparator: Group 1b: single dose MenACWY & paracetamol
Participants will receive a single dose of MenACWY plus paracetamol
Biological: MenACWY single dose + paracetamol
Single dose of MenACWY + 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
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

Active Comparator: Group 1d: two dose MenACWy/saline & paracetamol
Participants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol
Biological: MenACWY prime & saline placebo boost + paracetamol
MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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).

  8. 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)

  9. 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

  10. 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



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04536051


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

Locations
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Brazil
Instituto D'Or de Pesquisa e Ensino - I'Dor Recruiting
Salvador, Bahia, Brazil, 41253-190
Principal Investigator: Ana Verena Mendes         
Centro de Pesquisas Clinicas de Natal (CPCLIN) Recruiting
Natal, Rio Grande Do Norte, Brazil, 59025-050
Principal Investigator: Eveline Pipolo Milan         
Hospital das Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Principal Investigator: Eduardo Sprinz         
Universidade Federal de Santa Maria (UFSM) Recruiting
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
Principal Investigator: Alexandre Vargas Schwarzbold         
Instituto D'Or de Pesquisa e Ensino - I'Dor Recruiting
Rio de Janeiro, Brazil, 22281-100
Principal Investigator: Ana Maria Pitella de Souze Leite         
CRIE, Universidade Federal de São Paulo Recruiting
São Paulo, Brazil, 04038-001
Principal Investigator: Lily Weckx         
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: NCT04536051    
Other Study ID Numbers: COV003
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: September 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
Infections
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics