Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 8:03 PM
Study NCT ID:
NCT04536051
Status:
UNKNOWN
Last Update Posted:
2020-11-27
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Candidate COVID-19 Vaccine (COV003)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090985', 'term': 'ChAdOx1 nCoV-19'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'C525703', 'term': 'MenACWY'}], 'ancestors': [{'id': 'D019444', 'term': 'Vaccines, DNA'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR', 'timeFrame': '12 months post final vaccination', 'description': 'COVID-19 virologically confirmed symptomatic cases (PCR positive).'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '7 days post vaccination', 'description': 'Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)'}, {'measure': 'Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events', 'timeFrame': '12 months post final vaccination', 'description': 'Occurrence of serious adverse events'}, {'measure': 'Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease', 'timeFrame': '12 months post final vaccination', 'description': 'Occurrence of episodes; intensified disease'}, {'measure': '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', 'timeFrame': '12 months post final vaccination', 'description': 'Hospitalization for COVID-19 disease confirmed by PCR'}, {'measure': 'Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR', 'timeFrame': '12 months post final vaccination', 'description': 'COVID-19 serious disease confirmed by PCR'}, {'measure': 'Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease', 'timeFrame': '6 months', 'description': 'Death associated with COVID-19 disease'}, {'measure': '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)', 'timeFrame': '12 months post final vaccination', 'description': 'Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).'}, {'measure': 'Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates)', 'timeFrame': '12 months post final vaccination', 'description': 'Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)'}, {'measure': 'Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus', 'timeFrame': '12 months post final vaccination', 'description': 'Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus'}, {'measure': 'Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine', 'timeFrame': '12 months post final vaccination', 'description': 'Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'ChAdOx1 nCov19', 'sars-cov-2', 'vaccine'], 'conditions': ['Coronavirus']}, 'referencesModule': {'references': [{'pmid': '40686533', 'type': 'DERIVED', 'citation': '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': '39675209', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.', 'detailedDescription': '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.\n\nAll 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults from 18 to 55 years of age\n* Adults aged 56-69 years old (after review of safety data by DSMB in this age group in the UK trial)\n* Adults aged 70 and above years old (after review of safety data by DSMB in this age group in the UK trial)\n* Able and willing (in the Investigator's opinion) to fulfill all study requirements;\n* Health professionals and adults at high risk of exposure to SARS-CoV-2, as defined in section 5.2 of this protocol;\n* 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.\n* 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\n* 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);\n* Consent to abstain from blood donation during the course of the study;\n* Provide informed consent in writing\n\nExclusion Criteria:\n\n* 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.\n* Participation in SARS-CoV-2 serological research where participants are informed of their serological status during the course of the study;\n* Planned receipt of any vaccine (authorized or investigational), within 30 days before and after vaccination;\n* 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);\n* Administration of immunoglobulins and/or any blood products in the three months prior to the planned administration of the candidate vaccine;\n* 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);\n* History of allergic disease or reactions possibly exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY or paracetamol;\n* Any history of angioedema;\n* Any history of anaphylaxis;\n* Pregnancy, lactation or willingness/intention to become pregnant during the study;\n* Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);\n* History of severe psychiatric illness that possibly affects your participation in the study;\n* Hemorrhagic disorder (for example, factor deficiency, coagulopathy or platelet disorder), or a previous history of significant bleeding or bruising after IM injections or venipuncture;\n* Current suspected or known dependence on alcohol or drugs;\n* 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);\n* History of COVID-19 confirmed by laboratory;\n* 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\n* Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);\n* 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.\n\nRe-vaccination exclusion criteria (two-dose groups only)\n\n* Anaphylactic reaction following administration of vaccine\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT04536051', 'briefTitle': 'A Study of a Candidate COVID-19 Vaccine (COV003)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine', 'orgStudyIdInfo': {'id': 'COV003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1a: single dose ChAdOx & paracetamol', 'description': 'Participants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol', 'interventionNames': ['Biological: ChAdOx1 nCoV-19 single dose + paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1b: single dose MenACWY & paracetamol', 'description': 'Participants will receive a single dose of MenACWY plus paracetamol', 'interventionNames': ['Biological: MenACWY single dose + paracetamol']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1c: two dose ChAdOx & paracetamol', 'description': 'Participants will receive two standard doses of ChAdOx1 nCoV-19 vaccine, 4-12 weeks apart, plus paracetamol', 'interventionNames': ['Biological: ChAdOx1 nCoV-19 two dose + paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1d: two dose MenACWy/saline & paracetamol', 'description': 'Participants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol', 'interventionNames': ['Biological: MenACWY prime & saline placebo boost + paracetamol']}], 'interventions': [{'name': 'ChAdOx1 nCoV-19 single dose + paracetamol', 'type': 'BIOLOGICAL', 'description': 'Single dose of ChAdOx1nCOV19 vaccine, 5x10\\^10 vp + paracetamol', 'armGroupLabels': ['Group 1a: single dose ChAdOx & paracetamol']}, {'name': 'MenACWY single dose + paracetamol', 'type': 'BIOLOGICAL', 'description': 'Single dose of MenACWY + paracetamol', 'armGroupLabels': ['Group 1b: single dose MenACWY & paracetamol']}, {'name': 'ChAdOx1 nCoV-19 two dose + paracetamol', 'type': 'BIOLOGICAL', 'description': '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', 'armGroupLabels': ['Group 1c: two dose ChAdOx & paracetamol']}, {'name': 'MenACWY prime & saline placebo boost + paracetamol', 'type': 'BIOLOGICAL', 'description': 'MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol', 'armGroupLabels': ['Group 1d: two dose MenACWy/saline & paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Verena Mendes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Instituto D'Or de Pesquisa e Ensino - I'Dor", 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '59025-050', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Eveline Pipolo Milan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Pesquisas Clinicas de Natal (CPCLIN)', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Eduardo Sprinz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '97105-900', 'city': 'Santa Maria', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Alexandre Vargas Schwarzbold', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidade Federal de Santa Maria (UFSM)', 'geoPoint': {'lat': -29.68417, 'lon': -53.80694}}, {'zip': '22281-100', 'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Maria Pitella de Souze Leite', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Instituto D'Or de Pesquisa e Ensino - I'Dor", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04038-001', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Lily Weckx', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CRIE, Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Volunteer Recruitment Coordinator', 'role': 'CONTACT', 'email': 'vaccinetrials@ndm.ox.ac.uk', 'phone': '01865 611424'}], 'overallOfficials': [{'name': 'Andrew Pollard, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}