Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:49 AM
Study NCT ID:
NCT05289206
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2021-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine (ChAdOx1-S/nCoV-19 \\[recombinant\\]).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4446}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein', 'timeFrame': 'change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination', 'description': 'Detection and titration of antibodies against SARS-CoV-2 at baseline (Day 0) and at Day 90 and Day 180 after booster vaccination'}], 'secondaryOutcomes': [{'measure': 'Profile of the cell-mediated immune response in a subgroup of participants through cell immunophenotyping, using the Flow Cytometry (FC) technique.', 'timeFrame': 'change from baseline profile (Day 0) of the cell-mediated immune response compared to Day 90 (D90) and Day 180 (D180) after booster vaccination', 'description': '• Profile of the cell-mediated immune response in a subgroup of participants, before (D0), at D90 and D180 after booster vaccination through cell immunophenotyping, using the Flow Cytometry (FC) technique. Memory T and B cell subpopulations will be labeled with monoclonal antibodies conjugated to pre-especified fluorochromes that bind to specific surface markers (clusters of differentiation) present in the populations of interest.'}, {'measure': 'Ability of the serum from a subgroup of participants to neutralize antibodies though viral neutralization assay at baseline (Day 0) and at Day 90 and D180 after vaccine booster dose', 'timeFrame': 'change from baseline (Day 0) profile of the ability to neutralize antibodies in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination', 'description': '• Ability to neutralize antibodies in a subgroup of participants, through the Viral Neutralization Test (VNT) consisting of cultured Vero CCL-81 cells, inactivated serial diluted serum and fixation.'}, {'measure': 'Quantification of memory cell populations in a subgroup of participants', 'timeFrame': 'change from baseline (Day 0) memory cell populations in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination', 'description': '• Profile of memory populations by cellular immunophenotyping in a subgroup of participants at baseline (Day 0) and in Day 90 and Day 180 after booster vaccination.'}, {'measure': 'Physical activity and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.', 'timeFrame': 'change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of physical activity', 'description': '• Detection and titration of antibodies against SARS-CoV-2 and relationship with the history of physical activity during the follow-up period. To access physical activity the International Physical Activity Questionnaire (IPAQ) will be used and combined with the Duke Activity Status Index (DASI) questionnaire for sedentary lifestyle.'}, {'measure': 'Sedentary lifestyle and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.', 'timeFrame': 'change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of sedentary lifestyle', 'description': '• Detection and titration of antibodies against SARS-CoV-2 and relationship with the history of sedentary lifestyle during the follow-up period. To access the sedentary lifestyle the Duke Activity Status Index (DASI) questionnaire will be used and combined with International Physical Activity Questionnaire (IPAQ) for physical activity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'vaccine', 'ChAdOx1-S/nCoV-19 [recombinant]'], 'conditions': ['Comorbidities and Coexisting Conditions', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine.', 'detailedDescription': 'Intervention: Oxford/AstraZeneca - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac\n\nInclusion criteria:\n\n* Have voluntarily participated and be in regular follow-up monitoring by the COVACMANAUS study;\n* Have completed the vaccination schedule with 2 doses of CoronaVac, as per the COVACMANAUS study protocol for at least 180 days (+/- 30 days);\n* Demonstrate availability to be followed during the follow-up period defined in the study, through visits, telephone contacts or other digital means of communication;\n* Accept to participate in this new study for 6 (six) months.\n\nExclusion criteria\n\n* Confirmed diagnosis of COVID-19 within the last 28 days (antigen test or RT-PCR). In this situation, vaccination can be postponed until the participant completes 30 days;\n* Report of fever within 72 hours prior to vaccination (inclusion can be postponed until the participant completes 72 hours without fever and COVID-19 is discarded);\n* Having received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study;\n* Any other condition that, in the opinion of the Principal Investigator or its medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol;\n* Pregnancy or lactation.\n\nType of study/study design: Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine.\n\nSample size: all active participants from the COVACManaus study (up to 5071)\n\nPrimary outcome: Detection and titration of antibodies against SARS-CoV-2 before (D0), at D90 and D180 after booster vaccination\n\nSecondary outcomes:\n\n* Profile of the cell-mediated immune response in a subgroup of participants, before (D0), at D90 and D180 after booster vaccination;\n* Ability to neutralize antibodies in a subgroup of participants before (D0), in D90 and D180 after the vaccine booster;\n* Memory cell populations in a subgroup of participants before (D0), in D90 and D180 after booster vaccination.\n* Detection and titration of antibodies against SARS-CoV-2 and its association with the history of physical activity or sedentary lifestyle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Have voluntarily participated and be in regular follow-up monitoring by the COVACMANAUS study;\n* Have completed the vaccination schedule with 2 doses of CoronaVac, as per the COVACMANAUS study protocol for at least 180 days (+/- 30 days);\n* Demonstrate availability to be followed during the follow-up period defined in the study, through visits, telephone contacts or other digital means of communication;\n* Accept to participate in this new study for 6 (six) months.\n\nExclusion criteria\n\n* Confirmed diagnosis of COVID-19 within the last 28 days (antigen test or RT-PCR). In this situation, vaccination can be postponed until the participant completes 30 days;\n* Report of fever within 72 hours prior to vaccination (inclusion can be postponed until the participant completes 72 hours without fever and COVID-19 is discarded);\n* Having received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study;\n* Any other condition that, in the opinion of the Principal Investigator or its medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol;\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT05289206', 'acronym': 'COVACManaus2', 'briefTitle': 'Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity', 'organization': {'class': 'OTHER', 'fullName': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado'}, 'officialTitle': 'The Effects of the Interchangeability of the Booster Vaccine Against COVID-19 on the Immune Response Among Education and Public Safety Workers With Risk Factors for Severity, in Manaus (Amazonas)', 'orgStudyIdInfo': {'id': 'CAAE: 51701821.6.0000.0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - single arm', 'description': 'Oxford/AstraZeneca (ChAdOx1-S/nCoV-19 \\[recombinant\\]) - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac', 'interventionNames': ['Other: Vaccine - ChAdOx1-S/nCoV-19 [recombinant]']}], 'interventions': [{'name': 'Vaccine - ChAdOx1-S/nCoV-19 [recombinant]', 'type': 'OTHER', 'description': 'ChAdOx1-S/nCoV-19 \\[recombinant\\] - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac', 'armGroupLabels': ['Intervention - single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69040000', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'facility': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}], 'overallOfficials': [{'name': 'Marcus Lacerda, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM)', 'class': 'UNKNOWN'}, {'name': 'XP Investimentos', 'class': 'UNKNOWN'}, {'name': 'Universidade do Estado do Amazonas (UEA)', 'class': 'UNKNOWN'}, {'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}