Trials / Recruiting
RecruitingNCT06832514
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- University Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-01-31
- Primary completion
- 2026-07-31
- Completion
- 2026-12-31
- First posted
- 2025-02-18
- Last updated
- 2026-01-20
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT06832514. Inclusion in this directory is not an endorsement.