Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT05105295
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D015658', 'term': 'HIV Infections'}], '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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rate', 'timeFrame': '28 days after the 3th dose (Day 28)', 'description': 'The rate of seroconversion against coronavirus'}, {'measure': 'Neutralizing antibody level', 'timeFrame': 'Before the 3th dose (Day 0)', 'description': 'Neutralizing antibody GMT against coronavirus before the 3th dose'}, {'measure': 'Neutralizing antibody level', 'timeFrame': '28 days after the 3th dose (Day 28)', 'description': 'Neutralizing antibody GMT against coronavirus after the 3th dose'}, {'measure': 'Neutralizing antibody level', 'timeFrame': '6 months after the 3th dose', 'description': 'Neutralizing antibody GMT against coronavirus after the 3th dose'}], 'secondaryOutcomes': [{'measure': 'Adverse events rate', 'timeFrame': '0-21days following vaccinations', 'description': 'Analyse the incidence of adverse events following vaccination, both solicited and unsolicited'}, {'measure': 'Serious adverse event rate', 'timeFrame': '0-6 months', 'description': 'Report and analyse serious adverse events'}, {'measure': 'T cell count', 'timeFrame': 'before the 3th dose (Day 0)', 'description': 'T cell count （CD4+T，CD8+T，etc.）'}, {'measure': 'T cell count', 'timeFrame': '28 days after the 3th dose (Day 28)', 'description': 'T cell count （CD4+T，CD8+T，etc.）'}, {'measure': 'HIV viral load', 'timeFrame': 'before the 3th dose (Day 0)', 'description': 'HIV viral load'}, {'measure': 'HIV viral load', 'timeFrame': '28 days after the 3th dose (Day 28)', 'description': 'HIV viral load'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .', 'detailedDescription': 'The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.\n\nBlood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination.\n\nAny local or systemic adverse events that occurred within 21 days after vaccination will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged ≥18.\n* Body temperature \\< 37.3 ° C confirmed by clinical examination before enrollment .\n* Subjects who meet the diagnostic criteria for HIV infection and AIDS.\n* CD4+ count is less than 500/ul and more than 50/ul .\n* Female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment.\n* Able and willing to complete the entire study plan during the study follow-up period.\n* Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol.\n* Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;\n\nExclusion Criteria:\n\n* Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.\n* Being allergic to any component of vaccines (including excipients) .\n* Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.).\n* Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.\n* Injection of non-specific immunoglobulin within 1 month before enrollment.\n* Pregnant and lactating women.\n* The subjects are suffering from an acute illness; Or thrombocytopenia patients with platelet count \\< 20×10\\^9/L within three days before inoculation, that is, patients at high risk of spontaneous bleeding.\n* Acute HIV infection and opportunistic infection.\n* Subjects with co-opportunistic infections who did not receive antiviral therapy.\n* Subjects with CD4+ count less than 50/ul who have not received antiviral therapy.\n* HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).\n* Patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery.\n* Subjects who had vaccine-related adverse reactions after the second dose.\n* Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction.\n* Having any adverse nervous system reaction after the second dose.\n* Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.'}, 'identificationModule': {'nctId': 'NCT05105295', 'briefTitle': 'Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected', 'organization': {'class': 'INDUSTRY', 'fullName': 'China National Biotec Group Company Limited'}, 'officialTitle': 'Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected', 'orgStudyIdInfo': {'id': 'BIBP2021HIV-third dose'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Subjects receive a third dose of inactivated COVID-19 vaccine', 'interventionNames': ['Biological: Inactivated COVID-19 vaccine']}], 'interventions': [{'name': 'Inactivated COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'receive a third dose of inactivated COVID-19 vaccine', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310051', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang provincial center for disease control and prevention', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hanqing He', 'role': 'CONTACT', 'email': 'hanqinghe@cdc.zj.cn', 'phone': '（0571）87115111'}], 'overallOfficials': [{'name': 'Hanqing He', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zhejiang Provincial Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'Beijing Institute of Biological Products Co Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}