Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender a… (NCT06832514) | Clinical Trial Compass
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Belgium250 participantsStarted 2025-01-31
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written signed informed consent form (ICF) obtained before any study-related activities.
. Participants aged between, and including, 18 and 50 years of age at the time of signing the ICF which equals with the time of the first study intervention.
. Participants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history andphysical examination at enrollment.
. Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
. POCBP (18-50 years of age) who are not pregnant or breastfeeding or planning to become pregnant during the clinical study.
. Transgender persons need to be under stable gender-affirming hormone therapy (GAHT) for at least 6 months. Compliance needs to be documented by hormonal lab tests.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterise humoral, adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Timeframe: From the first vaccination visit to two months post-primary vaccination
. POCBP must have a negative urine pregnancy test at each vaccination visit (Visit 1 and Visit 5) Refer to Section 8.6.5 for Pregnancy Testing.
. Participants who are willing and able to comply with the study procedures and are capable to comply with the requirements of the protocol (e.g. return for follow-up visits) as determined by the investigator.
Exclusion criteria
. Current or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.
. Household contact with and/or intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life.
. Transgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g. gonadotropin releasing hormone analogues).
. Current or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.
. Past or current confirmed or suspected immune-suppressive or immune-deficient condition, at the discretion of the investigator, including but not limited to blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders, lupus erythematosus and associated conditions or disorders (e.g. rheumatoid arthritis, scleroderma) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
. History of confirmed hypersensitivity, anaphylaxis and/or other severe allergic reactions (e.g., generalized urticaria, angioedema, bronchospasm) to any component of the study vaccine or excipients (sodium chloride, histidine, sucrose, kanamycin and water for injection), medical products, or medical equipment whose use is foreseen in this study, as determined by the investigator.
. Clinical conditions representing a contraindication for IM administration and blood draws, as judged by the investigator, e.g. thrombocytopenia or history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties.
. History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.