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

Conditions

• Neisseria Meningitidis

Eligibility Criteria

Sex

ALL

Age

18 Years - 25 Years

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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 Dates

Start date

Nov 4, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

125 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Trumenba group
• Experimental: Penbraya group

Primary Outcome Measure

Percentage of participants who are seroprotected [ Time Frame: Baseline, 28 days post-vaccination ]

Central Contacts

• Christina Rostad, MD
  404-727-2472
  [email protected]
• Jessica McCaffery, PhD
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA