Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-04-02 @ 10:56 AM
Study NCT ID:
NCT02710851
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577000', 'term': 'hecolin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2016-03-12', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody)', 'timeFrame': '7 months'}, {'measure': 'Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)', 'timeFrame': '7 months'}], 'secondaryOutcomes': [{'measure': 'Number of serious adverse events throughout the study', 'timeFrame': '7 months', 'description': 'All the serious adverse events throughout the study would be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['human papillomavirus vaccine', 'condylomata acuminata'], 'conditions': ['Condylomata Acuminata']}, 'descriptionModule': {'briefSummary': 'This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants aged between 18 and 55 years.\n2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.\n3. Written informed consent obtained from the participants.\n4. Able to comply with the requests of the study.\n5. Axillary temperature not higher than 37.0°C\n6. Non-pregnancy verified by a urine pregnancy test.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding or plan to be pregnant within 7 months.\n2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.\n3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.\n4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine.\n5. Administration of any attenuated live vaccines within 30 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.\n6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.\n7. Having the plan to participate another clinical trial during the study period.\n8. Received another HPV vaccine.\n9. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).\n10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.\n11. Having serious disease of internal medicine, such as hypertension, cardiac disease, diabetes, hyperthyroidism et al.\n12. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.\n13. Diagnosed coagulant function abnormality (i.e., clotting factors absent, clotting hemorrhagic disease, abnormal platelet function) or blood coagulation disorder.\n14. Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.\n15. Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or h a tendency to commit suicide.\n16. Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent."}, 'identificationModule': {'nctId': 'NCT02710851', 'briefTitle': 'Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years', 'orgStudyIdInfo': {'id': 'HPV-PRO-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dosage HPV Vaccine(1:1)', 'description': 'Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio.', 'interventionNames': ['Biological: low dosage HPV Vaccine(1:1)']}, {'type': 'EXPERIMENTAL', 'label': 'low dosage HPV Vaccine(1:2)', 'description': 'Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:2 ratio.', 'interventionNames': ['Biological: low dosage HPV Vaccine(1:2)']}, {'type': 'EXPERIMENTAL', 'label': 'high dosage HPV Vaccine(1:1)', 'description': 'Participants in this arm would receive high dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio.', 'interventionNames': ['Biological: high dosage HPV Vaccine(1:1)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hepatitis E vaccine,Hecolin®', 'description': 'Participants in this arm would receive Hepatitis E vaccine,Hecolin®', 'interventionNames': ['Biological: Hepatitis E vaccine,Hecolin®']}], 'interventions': [{'name': 'low dosage HPV Vaccine(1:1)', 'type': 'BIOLOGICAL', 'description': 'Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.\n\nAll participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.', 'armGroupLabels': ['low dosage HPV Vaccine(1:1)']}, {'name': 'low dosage HPV Vaccine(1:2)', 'type': 'BIOLOGICAL', 'description': 'Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio.\n\nAll participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.', 'armGroupLabels': ['low dosage HPV Vaccine(1:2)']}, {'name': 'high dosage HPV Vaccine(1:1)', 'type': 'BIOLOGICAL', 'description': 'Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.\n\nAll participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.', 'armGroupLabels': ['high dosage HPV Vaccine(1:1)']}, {'name': 'Hepatitis E vaccine,Hecolin®', 'type': 'BIOLOGICAL', 'description': 'Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.', 'armGroupLabels': ['Hepatitis E vaccine,Hecolin®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jun Zhang, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiamen University'}, {'name': 'Yuemei Hu, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu center for Disease Prevention and Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jun Zhang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiamen Innovax Biotech Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Xiamen University'}}}}