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

NCT06832514 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Meningococcal Meningitis, Serogroup B
  • Transgender Persons
  • Sex Differences in Immune Response
  • Vaccination

Interventions

BIOLOGICAL

Serogroup B meningococal vaccine

The 4CMenB vaccine will be administered via two intramuscular (IM) injections in the non-dominant upper arm, with a one month interval.

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Centre for Vaccinology - CEVAC

    collaborator UNKNOWN

  • University Ghent

    lead OTHER

Principal Investigators

  • Prof. Dr. Isabel Leroux-Roels, PhD, MD · CEVAC, University Hospital Ghent, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832514 on ClinicalTrials.gov