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Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons

Study acronym: Vaxxygender
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated January 20, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 31, 2025 to Jul 31, 2026v3 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoint revised
  2. Primary endpoint revised
    • Secondary endpoint revised
    • Site contact updated
    • Collaborators revised (2)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06832514
Lead Sponsor University Ghent
Collaborators: University Hospital, Ghent, Centre for Vaccinology - CEVAC
Conditions
(from sponsor)		 Meningococcal Meningitis, Serogroup B, Transgender Persons, Sex Differences in Immune Response, Vaccination
Related terms Coitus, Meningitis, Meningococcal
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov