Recruiting

Meningitis B Vaccination

Sponsor:

Emory University

Code:

NCT07197762

Conditions

Neisseria Meningitidis

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Trumenba

PENBRAYA

Study Details

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

Study ID

NCT07197762

Start date

Nov 4, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Trumenba group

experimental: Penbraya group

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Christina Rostad, MD

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

Jessica McCaffery, PhD

jessica.mccaffery@emory.edu

Locations

Emory Children's Center-Vaccine Research Clinic

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Christina Rostad, MD

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

Hope Clinic

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Christina Rostad, MD

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

More Information

Sponsor

Emory University

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-22.