NCT07197762

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

Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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?

Detailed description

Neisseria meningitidis is a human-restricted pathogen that colonizes the nasopharynx and, in rare cases, invades the bloodstream or central nervous system, leading to invasive meningococcal disease (IMD). Clinical manifestations may include meningitis, septicemia, or both. Among the 12 known serogroups, five-A, B, C, W, and Y-account for the majority of global IMD cases. In the United States, serogroups B, C, W, and Y are responsible for approximately 78% of cases across all age groups, with serogroup B being the most prevalent in Europe. IMD incidence is highest among infants and children under 5 years, adolescents and young adults (particularly ages 16-21), and older adults aged 65 and above. Vaccination Landscape: Two monovalent MenB vaccines are currently licensed in the U.S.: * MenB-4C (Bexsero, GSK) * MenB-FHbp (Trumenba, Pfizer) In October 2023, the FDA approved MenACWY-TT/MenB-FHbp (Penbraya, Pfizer), a pentavalent vaccine targeting serogroups A, B, C, W, and Y for individuals aged 10-25 years. The CDC's Advisory Committee on Immunization Practices (ACIP) recommends Penbraya for: 1. Healthy individuals aged 16-23 years when shared clinical decision-making supports MenB vaccination 2. Individuals aged ≥10 years are at increased risk for IMD Due to antigenic differences between MenB-4C and MenB-FHbp (with only one shared antigen), these vaccines are not interchangeable. Continuity with the same manufacturer is required for subsequent doses to ensure immunogenic consistency. Study Purpose: This clinical trial aims to characterize the immunogenicity of a single dose of MenB-FHbp (Trumenba) or MenACWY-TT/MenB-FHbp (Penbraya) in young adults previously primed with a two-dose series of the heterologous MenB-4C (Bexsero) vaccine. The study will evaluate: Primary Objective: The proportion of participants achieving seroprotection (defined as hSBA titers ≥ lower limit of quantification \[LLOQ\]) against four MenB indicator strains at baseline and 28 days post-vaccination Secondary Objectives: * Geometric mean titers (GMTs) of hSBA responses to the four MenB strains * Proportion of participants with composite seroprotection (hSBA ≥LLOQ for all four strains) * Proportion achieving seroresponse (≥4-fold rise in hSBA titers from baseline)

Conditions

• Neisseria Meningitidis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-09-29
• Last updated: 2025-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study