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

NCT04536051 | Unknown Phase 3 DMC

• 1 other identifier: COV003
• Study Type: interventional
• Target: 10,300
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Coronavirus

Keywords

Covid-19; ChAdOx1 nCov19; sars-cov-2; vaccine

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR

  COVID-19 virologically confirmed symptomatic cases (PCR positive).

  12 months post final vaccination

Secondary Outcomes (10)

• 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

  7 days post vaccination

• Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events

  12 months post final vaccination

• Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease

  12 months post final vaccination

• 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

  12 months post final vaccination

• Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR

  12 months post final vaccination

Study Arms (4)

Group 1a: single dose ChAdOx & paracetamol

EXPERIMENTAL

Participants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol

Biological: ChAdOx1 nCoV-19 single dose + paracetamol

Group 1b: single dose MenACWY & paracetamol

ACTIVE COMPARATOR

Participants will receive a single dose of MenACWY plus paracetamol

Biological: MenACWY single dose + paracetamol

Group 1c: two dose ChAdOx & paracetamol

EXPERIMENTAL

Participants will receive two standard doses of ChAdOx1 nCoV-19 vaccine, 4-12 weeks apart, plus paracetamol

Biological: ChAdOx1 nCoV-19 two dose + paracetamol

Group 1d: two dose MenACWy/saline & paracetamol

ACTIVE COMPARATOR

Participants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol

Biological: MenACWY prime & saline placebo boost + paracetamol

Interventions

ChAdOx1 nCoV-19 single dose + paracetamol BIOLOGICAL

Single dose of ChAdOx1nCOV19 vaccine, 5x10\^10 vp + paracetamol

Group 1a: single dose ChAdOx & paracetamol

MenACWY single dose + paracetamol BIOLOGICAL

Single dose of MenACWY + paracetamol

Group 1b: single dose MenACWY & paracetamol

ChAdOx1 nCoV-19 two dose + paracetamol BIOLOGICAL

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 1c: two dose ChAdOx & paracetamol

MenACWY prime & saline placebo boost + paracetamol BIOLOGICAL

MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol

Group 1d: two dose MenACWy/saline & paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (6)

Instituto D'Or de Pesquisa e Ensino - I'Dor

Salvador, Estado de Bahia, 41253-190, Brazil

RECRUITING

Centro de Pesquisas Clinicas de Natal (CPCLIN)

Natal, Rio Grande do Norte, 59025-050, Brazil

RECRUITING

Hospital das Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Universidade Federal de Santa Maria (UFSM)

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

RECRUITING

Instituto D'Or de Pesquisa e Ensino - I'Dor

Rio de Janeiro, 22281-100, Brazil

RECRUITING

CRIE, Universidade Federal de São Paulo

São Paulo, 04038-001, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 40686533 DERIVED

• 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.

  PMID: 39675209 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

ChAdOx1 nCoV-19; Acetaminophen; MenACWY

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Andrew Pollard, Prof

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volunteer Recruitment Coordinator

CONTACT

01865 611424; vaccinetrials@ndm.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 2, 2020
• Study Start: June 2, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-09

Locations

BR (6)