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New treatment option for Meningococcal Meningitis, Serogroup B
Official title Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
ClinicalTrials.gov ID: NCT06832514
What this study is testing
What is Serogroup B meningococal vaccine?
Serogroup B meningococal vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for meningococcal meningitis, serogroup b.
Also referred to as Four component meningococcal serogroup B vaccine, 4CMenB.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history...
- 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.
You likely can't join if
- 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...
- Transgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g...
- 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...
- History of confirmed hypersensitivity, anaphylaxis and/or other severe allergic reactions (e.g., generalized urticaria, angioedema, bronchospasm) to...
See the full eligibility 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.
- 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.
- 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...
- 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...
- 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...
- History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- 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...
- History of idiopathic urticaria within the past year.
- 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...
- 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 (\ 20 cigarettes per day) or daily heavy...
- 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...
- Donation of blood or blood products within 90 days prior to the first vaccination visit (Visit 1) until Day 56 (Visit 9).
- Previous vaccination against any group B meningococcal vaccine (Bexsero®, Trumenba®) at any time prior to informed consent.
- 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...
- 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...
- 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.
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.