Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
10300 participants
INTERVENTIONAL
2020-06-02
2021-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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Group 1a: single dose ChAdOx & paracetamol
Participants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol
ChAdOx1 nCoV-19 single dose + paracetamol
Single dose of ChAdOx1nCOV19 vaccine, 5x10\^10 vp + paracetamol
Group 1b: single dose MenACWY & paracetamol
Participants will receive a single dose of MenACWY plus paracetamol
MenACWY single dose + paracetamol
Single dose of MenACWY + paracetamol
Group 1c: two dose ChAdOx & paracetamol
Participants will receive two standard doses of ChAdOx1 nCoV-19 vaccine, 4-12 weeks apart, plus paracetamol
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
Group 1d: two dose MenACWy/saline & paracetamol
Participants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol
MenACWY prime & saline placebo boost + paracetamol
MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol
Interventions
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ChAdOx1 nCoV-19 single dose + paracetamol
Single dose of ChAdOx1nCOV19 vaccine, 5x10\^10 vp + paracetamol
MenACWY single dose + paracetamol
Single dose of MenACWY + paracetamol
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
MenACWY prime & saline placebo boost + paracetamol
MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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 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;
* 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.
* Anaphylactic reaction following administration of vaccine
* Pregnancy
18 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Andrew Pollard, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Instituto D'Or de Pesquisa e Ensino - I'Dor
Salvador, Estado de Bahia, Brazil
Centro de Pesquisas Clinicas de Natal (CPCLIN)
Natal, Rio Grande do Norte, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Federal de Santa Maria (UFSM)
Santa Maria, Rio Grande do Sul, Brazil
Instituto D'Or de Pesquisa e Ensino - I'Dor
Rio de Janeiro, , Brazil
CRIE, Universidade Federal de São Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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References
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Costa Clemens SA, Bibi S, Marchevsky NG, Aley PK, Cappuccini F, Davies SA, Gonzalez I, Kelly SC, Mujadidi YF, Pipolo Milan E, Schwarzbold AV, Sprinz E, Voysey M, Weckx LY, Wright D, Bansal H, Bergagard MAS, Isaacs AJ, Kelly EJ, Lan D, Morgan S, Shankar NK, Shoemaker K, Villafana TL, Lambe T, Green JA, Pollard AJ. Immunogenicity and Safety of ChAdOx1 nCoV-19 (AZD1222) as a Homologous Fourth-Dose Booster: A Substudy of the Phase 3 COV003 Trial in Brazil. Mayo Clin Proc Innov Qual Outcomes. 2025 Jul 11;9(4):100642. doi: 10.1016/j.mayocpiqo.2025.100642. eCollection 2025 Aug.
Conlin K, Jenkin D, de Whalley P, Weckx LY, Folegatti PM, Bibi S, Lambe T, Aley PK, Pollard AJ, Voysey M, Costa Clemens SA; COV003 Study Group. Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial. Vaccine. 2025 Jan 25;45:126582. doi: 10.1016/j.vaccine.2024.126582. Epub 2024 Dec 14.
Other Identifiers
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COV003
Identifier Type: -
Identifier Source: org_study_id