Sexual differences are a well-established source of biological variation in immune system functioning, with men often displaying lower adaptive immune responses (e.g. antibody production) to infections and vaccinations compared to women. The impact of sex and gender on immune responses and immune functioning warrants more in-depth investigation. This study is an investigator-initiated project aimed at prospectively assessing the immune response towards a vaccine in transgender and cisgender individuals. Transgender individuals retain their chromosomal sex while undergoing a significant hormonal shift that aligns with their experienced gender. Immune responses induced by the four-component meningococcal serogroup B (4CMenB; Bexsero®) vaccine will be evaluated in transgender individuals and compared with responses observed in cisgender individuals. Both humoral and cellular immune responses induced by two doses of the 4CMenB vaccine will be quantified and analysed. This approach is expected to provide new insights into the effects of gender and sex differences on innate and adaptive immune responses.
Written signed informed consent form (ICF) obtained before any study-related activities.
Participants 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.
Participants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history andphysical examination at enrollment.
Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
Current or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.
Household contact with and/or intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life.
Transgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g. gonadotropin releasing hormone analogues).
Current or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.
Parallel
Serogroup B meningococal vaccine
Biological/VaccineThe 4CMenB vaccine will be administered via two intramuscular (IM) injections in the non-dominant upper arm, with a one month interval.
Characterise humoral, adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
The human serum bactericidal antibody titers (hSBA) against reference strains for factor H binding protein (fHbp), Neisseria adhesin A (NadA) and Porine A (PorA) in transgender and cisgender participants.
Characterise the cellular (CD4+ and CD8+ T cell), adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
T cell-mediated immune responses in peripheral blood mononuclear cells (PBMCs) collected at different timepoints post-vaccination in 4CMen-B vaccinated transgender and cisgender participants.
Characterise innate immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years
* White blood cell counts and C-reactive protein levels at Day 0 and 28 (prior to primary and secondary vaccination, respectively), and 1, 3 and 7 days post-primary and secondary vaccination, as well as 56 days post-primary vaccination with 4CMenB in transgender and cisgender participants * Cytokine production measured at Day 0 and 28 (prior to primary and secondary vaccination, respectively), as well as 1, 3 and 7 days post-primary and secondary vaccination with 4CMenB between transgender and cisgender participants.
Cellular (CD4+ and CD8+ T cell), adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
T cell-mediated immune responses in PBMCs collected at Day 28 (prior to secondary vaccination), 7 days post-primary and secondary vaccination, as well as 180 days post-primary vaccination with 4CMenB in transgender and cisgender participants as confirmed by the presence of 4CMenB-specific CD4+ and CD8+ T cells producing at least CD40L, IFN-γ, IL-2, and/or TNF-α as measured by flow cytometry (intracellular cytokine staining).
Cellular, regulatory T (Treg) cell immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Treg cell-mediated immune responses in PBMCs collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), 7 days post-primary and secondary vaccination, as well as 56 and 180 days post-primary vaccination with 4CMenB in transgender and cisgender participants, measured by flow cytometry (intracellular cytokine staining).
Changes in gene expression and epigenetic modifications at the single-cell immunological level after administration of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Characterization of innate and adaptive immune responses by examining differentially expressed immune genes in PBMCs collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), 1, 3 and 7 days post-primary and secondary vaccination with 4CMenB in transgender and cisgender participants. Characterization of immune responses by examining expressed genes, changes in gene expression levels, changes in epigenetic responses, and enriched/activated pathways in PBMCs collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), 1, 3 and 7 days post-primary and secondary vaccination with 4CMenB in transgender and cisgender participants.
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University Ghent
Lead sponsor
University Hospital, Ghent
Collaborator
Centre for Vaccinology - CEVAC
Collaborator
