RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE for Healthy volunteers|Neisseria meningitidis serogroup B vaccination

Inclusion criteria

• {"criterion_text":"- 1.\tWritten signed informed consent form (ICF) obtained before any study-related activities.\n- 2.\tParticipants aged between, and including, 18 and 50 years of age at the time of signing the ICF which equals with the time of the first study intervention.\n- 3.\tParticipants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history andphysical examination at enrollment.\n- 4.\tParticipants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.\n- 5.\tPOCBP (18-40 years of age) who are not pregnant or breastfeeding or planning to become pregnant during the clinical study.\n- 6.\tTransgender persons need to be under stable gender-affirming hormone therapy (GAHT) for at least 6 months. Compliance needs to be documented by hormonal lab tests.\n- 7.\tPOCBP must have a negative urine pregnancy test at each vaccination visit (Visit 1 and Visit 5) Refer to Section 8.6.5 for Pregnancy Testing.\n- 8.\tParticipants who are willing and able to comply with the study procedures and are capable to comply with the requirements of the protocol (e.g. return for follow-up visits) as determined by the investigator."}

Exclusion criteria

• {"criterion_text":"- 1.\tCurrent or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.\n- 3.\tTransgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g. gonadotropin releasing hormone analogues).\n- 4.\tCurrent or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.\n- 5.\tPast or current confirmed or suspected immune-suppressive or immune-deficient condition, at the discretion of the investigator, including but not limited to blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders, lupus erythematosus and associated conditions or disorders (e.g. rheumatoid arthritis, scleroderma) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).\n- 6.\tHistory of confirmed hypersensitivity, anaphylaxis and/or other severe allergic reactions (e.g., generalized urticaria, angioedema, bronchospasm) to any component of the study vaccine or excipients (sodium chloride, histidine, sucrose, kanamycin and water for injection), medical products, or medical equipment whose use is foreseen in this study, as determined by the investigator.\n- 7.\tClinical conditions representing a contraindication for IM administration and blood draws, as judged by the investigator, e.g. thrombocytopenia or history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties.\n- 8. (former 10).\tHistory of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.\n- 9. (former 11).\tActive malignancy or malignancy within the past 5 years that, in the opinion of the investigator, may affect immune response or participant safety - except for localized and fully treated cancers not requiring long-term therapy such as chemotherapy or radiotherapy (e.g. completely resected basal cell carcinoma, cervical intraepithelial neoplasia, melanoma in situ, early-stage thyroid cancer), based on the investigator’s clinical judgement.\n- 10 (former 12).\tHistory of idiopathic urticaria within the past year.\n- 11 (former 13).\tCurrently pregnant, breast-feeding or planning to become pregnant. Cisgender women with permanent infertility due to an alternate medical cause (e.g. documented bilateral oophorectomy, androgen insensitivity, gonadal dysgenesis) are excluded to participate. For individuals with permanent infertility due to an alternate medical cause other than the above, investigator discretion should be applied to determining study entry. Additionally, cisgender women in a postmenopausal state, defined as no menses for 12 months without an alternative medical cause are also excluded to participate. Refer to Appendix 4 – Guidance on contraception and participants of childbearing potential.\n- 12 (former 14).\tAny other clinical condition that, in the opinion of the investigator, could compromise the participant’s safety and/or compliance with the study protocol (e.g. current or recent (< 1 years ago) heavy smoking (> 20 cigarettes per day) or daily heavy vaping (equivalent to 20 cigarettes)41 , drug- or alcohol (> 15 units for cisgender men and transgender women or > 10 units or cisgender women and transgender men per week) abuse/addiction.\n- 13 (former 15).\tBehavioral or cognitive impairment, unstable psychiatric conditions (e.g. forced admission, suicidal thoughts in the last two year) or other psychiatric disease that, in the opinion of the investigator, may interfere with study compliance, as well as with the subject’s ability and/or safety to participate in the study. Stable psychiatric conditions ( e.g. under-controlled depression) will be evaluated based on the investigators judgement.\n- 14 (former 16).\tDonation of blood or blood products within 90 days prior to the first vaccination visit (Visit 1) until Day 56 (Visit 9).\n- 2.\tHousehold contact with and/or intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life."}

Primary endpoints

• {"endpoint_text":"- Quantification of human serum bactericidal antibody titers (hSBA) against reference strains for factor H binding protein (fHbp), Neisseria adhesin A (NadA) and Porine A (PorA) in serum collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), and 56 days post-primary vaccination with 4CMenB in transgender and cisgender participants.","definition_or_measurement_approach":"Measurement of hSBA antibody titers in serum samples collected at Day 0, Day 28 (prior to secondary vaccination) and Day 56 post-primary vaccination against reference strains for fHbp, NadA and PorA."}
• {"endpoint_text":"- Comparison of hSBA antibody titers against reference strains for fHbp, NadA and PorA in serum samples collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), and 56 days post-primary vaccination with 4CMenB between transgender and cisgender participants.","definition_or_measurement_approach":"Comparative analysis of hSBA titers (same timepoints: Day 0, Day 28, Day 56) between transgender and cisgender participant groups."}

Secondary endpoints

• {"endpoint_text":"- Quantification of T cell-mediated immune responses in peripheral blood mononuclear cells (PBMCs) collected at Day 0 (prior to primary vaccination, baseline), and 56 days post-primary vaccination with 4CMenB in transgender and cisgender participants. The results will be expressed as frequencies of CD4+ or CD8+ T cells responding to 4CMenB antigen(s) and expressing two or more immune markers among CD40L, IFN-γ, IL-2, and TNF-α per million total CD4+ or CD8+ T cells as measured using intracellula","definition_or_measurement_approach":"Measurement of T cell responses in PBMCs at Day 0 and Day 56; results expressed as frequencies of CD4+ and CD8+ T cells expressing ≥2 markers among CD40L, IFN-γ, IL-2, TNF-α (measured by intracellular assays / flow cytometry; text truncated in source)."}
• {"endpoint_text":"- Comparison of T cell-mediated immune responses in PBMCs collected at Day 0 (prior to primary vaccination, baseline), and 56 days post-primary vaccination with 4CMenB between transgender and cisgender participants. The results will be expressed as frequencies of CD4+ or CD8+ T cells responding to MenB antigens and expressing two or more immune markers among CD40L, IFN-γ, IL-2 and TNF-α per million total CD4+ or CD8+ T cells as measured using intracellular cytokine staining and flow cytometry (I","definition_or_measurement_approach":"Comparative analysis of T cell-mediated responses (Day 0 vs Day 56) between transgender and cisgender groups; measured as frequencies per million CD4+/CD8+ T cells using intracellular cytokine staining and flow cytometry (source text truncated)."}

Methods

• K2_Recruitment material_ Boodschap_website_for publication — website recruitment material (document title indicates website message).
• K2_Recruitment material_ Social_Media_for publication — social media posts for recruitment (document title).
• K2_Recruitment material_ Intranet UZ mail_for pubilcation — intranet / internal email (document title).
• K2_Recruitment material_Email_for publication — email channel (document title).
• K2_Recruitment material_Flyer_TG_for publication — printed flyer targeting transgender persons (document title: TG = transgender).
• K2_Recruitment material_Flyer_CG_for publication — printed flyer targeting cisgender persons (document title: CG = cisgender).
• L2_SIS and ICF_PRE-SCREENING_CEVAC_for publication / L2 pre-screening materials — pre-screening questionnaires and REDCap instructions (documents present).

Belgium

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

11-08-2025

Processing Time Days

259

Number Of Sites

1

Number Of Participants

250

Primary sponsor

Full Name

Universiteit Gent

Organisation Type

Educational Institution

Country Of Registered Address

Belgium