Comparing Trumenba and Penbraya vaccines in young adults who previously received Bexsero
Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
This trial tests whether giving Trumenba or the new Penbraya vaccine boosts immune protection against meningitis B in young adults who got the two-dose Bexsero series years earlier.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT07197762 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional trial enrolls healthy young adults who completed a two-dose Bexsero (MenB-4C) primary series at least 2.5 years earlier and administers either Trumenba (MenB-FHbp) or the pentavalent Penbraya (MenACWY-TT/MenB-FHbp). Blood samples are taken before and after vaccination to measure bactericidal antibody titers against four representative MenB strains and to determine how many participants reach protective thresholds or show a marked rise in antibody levels. The study compares the proportion protected and the magnitude of the immune response between the two vaccine groups and monitors safety and pregnancy status per protocol. All vaccinations and follow-up visits occur at Emory-affiliated clinics in Atlanta.
Who should consider this trial
Good fit: Ideal candidates are healthy young adults who received a documented two-dose Bexsero (MenB-4C) series at least 2.5 years ago, can attend all study visits in Atlanta, and meet the study's pregnancy and contraception requirements.
Not a fit: People who have not received Bexsero, who are immunocompromised, currently pregnant, or unable to travel to the Atlanta sites are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the results could show whether switching to Trumenba or Penbraya increases protection for people primed with Bexsero and help guide vaccine recommendation decisions.
How similar studies have performed: Licensed MenB vaccines like Bexsero and Trumenba have produced protective antibody responses in prior studies, but direct evidence about switching from a Bexsero primary series to Trumenba or Penbraya is limited and is the gap this trial aims to fill.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory Children's Center-Vaccine Research Clinic — Atlanta, Georgia, United States (Recruiting)
- Hope Clinic — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Christina Rostad, MD — Emory University
- Study coordinator: Christina Rostad, MD
- Email: Christina.rostad@emory.edu
- Phone: 404-727-2472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.