NCT07197762 · Emory University
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
What this study is about
The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
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The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
Interventions
BIOLOGICAL
Trumenba
Trumenba is a sterile, recombinant vaccine targeting Neisseria meningitidis serogroup B. It contains two lipidated factor H binding protein (fHbp) variants-A05 from subfamily A and B01 from subfamily B-delivered in a 0.5 mL prefilled syringe. Each dose includes 120 µg of protein (60 µg per variant), 0.018 mg polysorbate 80, and 0.25 mg aluminum as AlPO₄, formulated in histidine-buffered saline at pH 6.0. A single intramuscular dose will be administered in the deltoid.
BIOLOGICAL
PENBRAYA
PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. It consists of two components: * A lyophilized MenACWY portion (polysaccharides conjugated to tetanus toxoid) * A liquid MenB portion (two recombinant fHbp variants: A05 and B01) Each 0.5 mL dose contains 20 µg of polysaccharides (5 µg per serogroup), 44 µg tetanus toxoid, 120 µg of MenB protein (60 µg per variant), plus stabilizers and aluminum phosphate. This will be administered intramuscularly in the deltoid.
Primary outcome measures
Percentage of participants who are seroprotected
Time frame: Baseline, 28 days post-vaccination
Percentage of participants who are seroprotected, defined as a human serum bactericidal antibody assay (hSBA) titer ≥LLOQ-Lower limit of quantification (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB indicator strains (A22, A56, B24, and B44) with Trumenba or Penbraya. Serum samples from V1 and V2 will be shipped in batches to Pfizer, where hSBA assays will be performed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provides written informed consent before any study procedures are performed.
- Be able to understand and agree to comply with planned study procedures and be available for all study visits.
- Subject is in good health as determined by vital signs, medical history, targeted physical examination (if indicated), and the judgment of the investigator.
- Vaccinated with 2-dose Bexsero primary series at least 2.5 years before vaccination. Must confirm vaccination status and dates of administration through GRITS, healthcare provider, or other official documentation
- Women of childbearing potential must agree to use or have practiced true abstinence2 or use at least one acceptable primary form of contraception from 28 days prior through 28 days after vaccination.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before vaccination
Exclusion criteria
- Subject has an acute illness with fever (temperature ≥100.4 °F) within 72 hours before vaccine administration.
- Subject is currently pregnant or breastfeeding an infant/child.
- Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. (Including acute, subacute, intermittent,t or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. Chronic medical conditions that are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.)
- Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after the study vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before through 4 weeks after the study vaccination.
- Any previous severe hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Received any MenB vaccine within the last 2.5 years before vaccination.
- Received more than 2 doses of Bexsero or any other MenB vaccine(s) (e.g. Trumenba or Penbraya)
- Any known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy \>20 mg per day for ≥14 days, or those receiving immunosuppressive therapy. Participants with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory condition or autoimmune condition requiring immunomodulatory treatment, including, but not limited to, Guillain-Barré syndrome, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Where
- Atlanta, Georgia
Collaborators
Pfizer
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 22, 2025 · Source of record for eligibility and locations