Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT05766904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570015', 'term': '4CMenB vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Block randomisation would be used to generate the list of treatment groups with a block size of 4 in a centralised computer by a staff in the Research Centre unrelated to data analysis. Group assignment would be concealed and performed by another staff unrelated to data analysis who will pick the group number from the random allocation sequence in sequential order. The subjects and investigators would therefore be blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants in the vaccination group would receive two doses of 4CMenB vaccine 1 month apart (at Month 0 and Month 1) while subjects in the control group would receive two doses of normal saline of a similar volume.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-11', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between incidence of NG between two groups', 'timeFrame': 'Month 2 to Month 24', 'description': 'Difference in NG incidences in the two groups'}], 'secondaryOutcomes': [{'measure': 'Changes in risk behaviours and networking pattern after vaccination', 'timeFrame': 'Month 2 to Month 24', 'description': 'Frequency of sex networking, number of sex partners, and use of condoms'}, {'measure': 'Safety profile of the vaccine', 'timeFrame': 'Month 2 to Month 24', 'description': 'Prevalence of adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gonorrhea', 'Sexually Transmitted Infection']}, 'descriptionModule': {'briefSummary': 'Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM).\n\nDesign: Parallel randomised double-blind placebo-controlled trial.\n\nSetting: A teaching hospital in Hong Kong.\n\nParticipants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transmitted infection \\[STI\\] diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria) would be recruited into the trial, with half allocated to intervention and control group each.\n\nIntervention: Intervention and control group would receive, one month apart, two doses of meningococcal vaccine and normal saline, respectively.\n\nMain outcome measures: Safety and efficacy of vaccine against gonorrhoea (time to first gonorrhoea infection and incidence), and behavioural change after vaccination.\n\nExpected results: NG incidences in two groups would be compared. Efficacy of vaccine against gonorrhoea would be determined after controlling confounding variables. Characteristics of participants with incident NG would be distinguished from those without incident infections. Change of frequency of sexual activities and networking would be noted.\n\nImplications: Strategies on STI screening and vaccination could be informed. Reduced STI burden post-vaccination could be measured with surveillance system.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male adult who has had sex with another male in the past six months\n* Ages 18 years or above\n* Normally resides in Hong Kong\n* Able to communicate in written and spoken Chinese or English\n* At risk of gonorrhoea infection (had condomless sex with more than one man within the last six months, history of STI diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria)\n* Negative NG test result at the time of recruitment\n* No history of previous vaccination with MenB vaccines\n* Able and willing to attend all study visits\n\nExclusion Criteria:\n\n* Contraindications to receive MenB vaccine\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT05766904', 'briefTitle': 'Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Efficacy of a Meningococcal B Vaccine Against Neisseria Gonorrhoeae Infections Among Men Who Have Sex With Men: a Randomised-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '21200912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intramuscular injection of 2 doses of 0.5mL 4CMenB vaccine 1 month apart', 'interventionNames': ['Biological: 4CMenB vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Intramuscular injection of 2 doses of 0.5mL placebo 1 month apart', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '4CMenB vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Bexsero'], 'description': 'Four-component MenB vaccine', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% Sodium Chloride Inj. B.P.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Stanley Ho Centre for Emerging Infectious Diseases', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Tsz Ho Kwan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jockey Club School of Public Health and Primary Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Tsz Ho Kwan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}