MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults

Recruiting now · Phase 4

Conditions studied: Neisseria Meningitidis

In brief

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. The main questions it aims to answer are: * How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine? * How strong is the immune response after vaccination, and how many people show a noticeable boost in immune response?

Key facts

Study ID

NCT07197762

Run by

Emory University

People needed

125

Starts

2025-11-04

Expected to finish

2026-12-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Emory Children's Center-Vaccine Research Clinic — Atlanta, Georgia, United States (enrolling)
• Hope Clinic — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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