Actively Recruiting
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Led by University Ghent · Updated on 2026-01-20
250
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University Ghent
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before any study activities
- Age between 18 and 50 years at first study intervention
- In good general health as determined by medical evaluation
- Body mass index between 18.5 and 35 kg/m2 at screening
- Not pregnant, breastfeeding, or planning pregnancy during the study
- Transgender participants on stable gender-affirming hormone therapy for at least 6 months with documented compliance
- Negative urine pregnancy test at each vaccination visit for participants of childbearing potential
- Willing and able to comply with study procedures and follow-up visits
You will not qualify if you...
- Current or past confirmed or suspected infection with N. meningitidis or N. gonnorrhoea
- Household or intimate contact with someone with laboratory-confirmed N. meningitidis infection
- Transgender persons in diagnostic phase without hormone treatment or on hormone-suppressing treatment
- Current or past infection with hepatitis B, hepatitis C, or HIV
- Immune-suppressive or immune-deficient conditions including autoimmune disorders or immunodeficiency syndromes
- History of severe allergic reactions to vaccine components or related medical products
- Conditions contraindicating intramuscular injections or blood draws such as bleeding disorders
- History of absence or removal of the spleen
- Active malignancy or malignancy within past 5 years affecting immune response or safety, except certain fully treated localized cancers
- History of idiopathic urticaria within past year
- Pregnant, breastfeeding, or planning pregnancy; certain permanent infertility or postmenopausal states also excluded
- Any clinical condition that may compromise safety or compliance including recent heavy smoking, vaping, or substance abuse
- Behavioral or cognitive impairments or unstable psychiatric conditions interfering with study participation
- Blood donation within 90 days before first vaccination until Day 56
- Prior vaccination with group B meningococcal vaccines
- Recent use or planned use of live-attenuated or other vaccines conflicting with study schedule
- Participation in other clinical studies or investigational treatments within 28 days prior to vaccination
- Recent or planned receipt of blood products or immunoglobulins
- Chronic immunosuppressant use including corticosteroids exceeding specified doses
- Use of certain hormonal contraceptives inhibiting ovulation in participants of childbearing potential
- Current tuberculosis treatment or prophylaxis
- Any medical condition that might interfere with study results or pose additional risk as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
CEVAC, University Hospital Ghent, Belgium
Ghent, Belgium, 9000
Actively Recruiting
Research Team
P
Prof. Dr. Isabel Leroux-Roels, PhD, MD
CONTACT
D
Dr. Valentino D'Onofrio, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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