Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 3:15 AM
Study NCT ID:
NCT05099757
Status:
UNKNOWN
Last Update Posted:
2021-12-06
First Post:
2021-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurrence of Adverse Events After Vaccination', 'timeFrame': 'Within 7 days after the vaccination', 'description': 'Occurrence of Adverse Events After Vaccination'}, {'measure': 'Occurrence of Adverse Events After Vaccination', 'timeFrame': 'Within 28 days after vaccination', 'description': 'Occurrence of Adverse Events After Vaccination'}], 'primaryOutcomes': [{'measure': 'Anti-HBs Seroconversion Rate at Months 1', 'timeFrame': 'Months 1', 'description': 'Anti-HBs Seroconversion Rate at Months 1'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 3', 'timeFrame': 'Months 3', 'description': 'Anti-HBs Seroconversion Rate at Months 3'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 7', 'timeFrame': 'Months 7', 'description': 'Anti-HBs Seroconversion Rate at Months 7'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 12', 'timeFrame': 'Months 12', 'description': 'Anti-HBs Seroconversion Rate at Months 12'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 18', 'timeFrame': 'Months 18', 'description': 'Anti-HBs Seroconversion Rate at Months 18'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 24', 'timeFrame': 'Months 24', 'description': 'Anti-HBs Seroconversion Rate at Months 24'}, {'measure': 'Anti-HBs Seroconversion Rate at Months 30', 'timeFrame': 'Months 30', 'description': 'Anti-HBs Seroconversion Rate at Months 30'}], 'secondaryOutcomes': [{'measure': 'Anti-HBs Concentration at Months 1', 'timeFrame': 'Months 1', 'description': 'Anti-HBs Concentration at Months 1'}, {'measure': 'Anti-HBs Concentration at Months 3', 'timeFrame': 'Months 3', 'description': 'Anti-HBs Concentration at Months 3'}, {'measure': 'Anti-HBs Concentration at Months 7', 'timeFrame': 'Months 7', 'description': 'Anti-HBs Concentration at Months 7'}, {'measure': 'Anti-HBs Concentration at Months 12', 'timeFrame': 'Months 12', 'description': 'Anti-HBs Concentration at Months 12'}, {'measure': 'Anti-HBs Concentration at Months 18', 'timeFrame': 'Months 18', 'description': 'Anti-HBs Concentration at Months 18'}, {'measure': 'Anti-HBs Concentration at Months 24', 'timeFrame': 'Months 24', 'description': 'Anti-HBs Concentration at Months 24'}, {'measure': 'Anti-HBs Concentration at Months 30', 'timeFrame': 'Months 30', 'description': 'Anti-HBs Concentration at Months 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Vaccine', 'Immunogenicity', 'Booster Dose', 'Long-term Immune Response', 'College Students'], 'conditions': ['Hepatitis B Vaccine']}, 'descriptionModule': {'briefSummary': 'The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.\n\nThis study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.', 'detailedDescription': 'Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged of 18 years or above\n* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment\n* Sign informed consent, willing to participate in this study\n\nExclusion Criteria:\n\n* Being pregnant\n* Intolerance or allergy to any component of the vaccine\n* Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever'}, 'identificationModule': {'nctId': 'NCT05099757', 'briefTitle': 'The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Medical University'}, 'officialTitle': 'The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students', 'orgStudyIdInfo': {'id': 'DXSHB20211012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 µg at month 0, months 0, 1 or 0, 1, and 6', 'description': '20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6', 'interventionNames': ['Biological: 20 µg dose hepatitis B vaccine']}], 'interventions': [{'name': '20 µg dose hepatitis B vaccine', 'type': 'BIOLOGICAL', 'description': 'one-dose, two-dose or three-dose, 20 µg per dose', 'armGroupLabels': ['20 µg at month 0, months 0, 1 or 0, 1, and 6']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Suping Wang, PhD', 'role': 'CONTACT', 'email': 'supingwang@sxmu.edu.cn', 'phone': '+86-351-4135103'}], 'overallOfficials': [{'name': 'Suping Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suping Wang', 'investigatorAffiliation': 'Shanxi Medical University'}}}}