An investigator-initiated, single-center academic study in healthy transgender and cisgender persons aged between 18 and 50 years to investigate gender and sex differences in immune responses to meningococcal serogroup B vaccination

Healthy volunteers

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., 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.

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, 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

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Belgium