RecruitingPhase 4NCT06832514

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

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


Sponsor

University Ghent

Enrollment

250 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Serogroup B meningococal vaccine for people with meningococcal meningitis, serogroup b, sex differences in immune response, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALSerogroup 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.


Locations(1)

CEVAC, University Hospital Ghent, Belgium

Ghent, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06832514


Related Trials