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

NCT07197762 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY000098362025P011916
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Neisseria Meningitidis

Keywords

MenACWY-TT/MenB-FHbp [Penbraya, Pfizer]; Meningococcus B; MenB-FHbp [Trumenba, Pfizer]; Neisseria meningitidis serogroup B

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who are seroprotected

  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.

  Baseline, 28 days post-vaccination

Secondary Outcomes (3)

• human Serum bactericidal antibody (hSBA) quantity

  Baseline, 28 days post-vaccination

• Percentage of participants who have composite seroprotection

  Baseline, 28 days post-vaccination

• Percentage of participants achieving seroresponse

  Baseline to 28 days post-vaccination

Study Arms (2)

Trumenba group

EXPERIMENTAL

Biological: Trumenba

Penbraya group

EXPERIMENTAL

Biological: PENBRAYA

Interventions

Trumenba BIOLOGICAL

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.

Trumenba group

PENBRAYA BIOLOGICAL

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.

Penbraya group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Emory University: lead
• Pfizer: collaborator

Study Sites (2)

Emory Children's Center-Vaccine Research Clinic

Atlanta, Georgia, 30329, United States

RECRUITING

Hope Clinic

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Interventions

MenB-FHbp vaccine

Study Officials

• Christina Rostad, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Rostad, MD

CONTACT

404-727-2472; Christina.rostad@emory.edu

Jessica McCaffery, PhD

CONTACT

jessica.mccaffery@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 29, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)