Examining immune responses to vaccination in transgender and cisgender individuals

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

This study tests how well the meningococcal serogroup B vaccine works in transgender and cisgender people by looking at their immune responses after getting the vaccine.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University Ghent (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Ghent)
• Trial ID: NCT06832514 on ClinicalTrials.gov

What this trial studies

This study investigates the differences in immune responses to the meningococcal serogroup B vaccine between transgender and cisgender individuals. It aims to assess both humoral and cellular immune responses after administering two doses of the vaccine. Participants aged 18 to 40, who are in good health and meet specific criteria, will be enrolled. The study focuses on understanding how gender and hormonal therapy influence vaccine efficacy in these populations.

Who should consider this trial

Good fit: Ideal candidates include transgender persons aged 18-40 who have been on stable gender-affirming hormone therapy for at least six months.

Not a fit: Patients outside the age range of 18-40 or those not undergoing gender-affirming hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to tailored vaccination strategies that improve immune responses in transgender individuals.

How similar studies have performed: While studies have explored immune responses in various populations, this specific focus on transgender individuals in relation to vaccination is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Written signed informed consent form (ICF) obtained before any study-related activities.
2. 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.
3. 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.
4. Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
5. POCBP (18-50 years of age) who are not pregnant or breastfeeding or planning to become pregnant during the clinical study.
6. 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.
7. 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.
8. 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:

1. Current or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.
2. Household contact with and/or intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life.
3. 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).
4. Current or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.
5. 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).
6. 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.
7. 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.
8. History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
9. Active malignancy or malignancy within the past 5 years that, in the opinion of the investigator, may affect immune response or participant safety - except for localized and fully treated cancers not requiring long-term therapy such as chemotherapy or radiotherapy (e.g. completely resected basal cell carcinoma, cervical intraepithelial neoplasia, melanoma in situ, early-stage thyroid cancer), based on the investigator's clinical judgement.
10. History of idiopathic urticaria within the past year.
11. Currently pregnant, breast-feeding or planning to become pregnant. Cisgender women with permanent infertility due to an alternate medical cause (e.g. documented bilateral oophorectomy, androgen insensitivity, gonadal dysgenesis) are excluded to participate. For individuals with permanent infertility due to an alternate medical cause other than the above, investigator discretion should be applied to determining study entry. Additionally, cisgender women in a postmenopausal state, defined as no menses for 12 months without an alternative medical cause are also excluded to participate. Refer to
12. Any other clinical condition that, in the opinion of the investigator, could compromise the participant's safety and/or compliance with the study protocol (e.g. current or recent (\< 1 years ago) heavy smoking (\> 20 cigarettes per day) or daily heavy vaping (equivalent to 20 cigarettes), drug- or alcohol (\> 15 units for cisgender men and transgender women or \> 10 units or cisgender women and transgender men per week) abuse/addiction.
13. Behavioral or cognitive impairment, unstable psychiatric conditions (e.g. forced admission, suicidal thoughts in the last two year) or other psychiatric disease that, in the opinion of the investigator, may interfere with study compliance, as well as with the subject's ability and/or safety to participate in the study. Stable psychiatric conditions (e.g. under-controlled depression) will be evaluated based on the investigators judgement.
14. Donation of blood or blood products within 90 days prior to the first vaccination visit (Visit 1) until Day 56 (Visit 9).
15. Previous vaccination against any group B meningococcal vaccine (Bexsero®, Trumenba®) at any time prior to informed consent.
16. Prior receipt of a live-attenuated vaccine in the 28 days prior to administration of the 4CMenB vaccine, within 14 days for subunit or inactivated vaccines or planning to receive a vaccine in between the first and second vaccine administration, as well as 28 days following administration of the second 4CMenB vaccine dose.
17. Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug or medical device in the 28 days prior to study vaccination.
18. Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of the study vaccine, or planning to receive such product during the study period.
19. Chronic administration (defined as 14 consecutive days in total) of immunosuppressants (e.g. corticosteroids (PO/IV/IM) or other immune-modifying drugs (e.g. antineoplastic agents, radiotherapy) during the period starting 90 days prior to vaccination or planned administration during the study (excluding topical, inhaled and intranasal preparations and intra-articular injections). For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent.
20. POCBP (cisgender women and transgender men) who use the following contraceptive methods will not be included in the study

    * Oral, injectable, intravaginal (i.e. intravaginal ring) or transdermal combined (oestrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation.
    * Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
21. Current anti-tuberculosis prophylaxis or therapy.

25\. Participants with a history of any medical conditions that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants when participating in the study.

Where this trial is running

Ghent

• CEVAC, University Hospital Ghent, Belgium — Ghent, Belgium (Recruiting)

Study contacts

• Principal investigator: Prof. Dr. Isabel Leroux-Roels, PhD, MD — CEVAC, University Hospital Ghent, Belgium
• Study coordinator: Prof. Dr. Isabel Leroux-Roels, PhD, MD

Conditions Meningococcal Meningitis, Serogroup B; Transgender Persons; Sex Differences in Immune Response; Vaccination; Gender