MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
ConditionNeisseria Meningitidis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-25
SponsorEmory University
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Trumenba
Biological/VaccineTrumenba 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/VaccinePENBRAYA 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.
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: Trumenba groupExperimental treatment 1 intervention
Group B: Penbraya groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, 28 days post-vaccinationSecondary outcomes
1
human Serum bactericidal antibody (hSBA) quantity
Human serum bactericidal antibody (hSBA) Geometric mean titer will be described for all 4 indicator strains of MenB
Time frame
Baseline, 28 days post-vaccination2
Percentage of participants who have composite seroprotection
Percentage of participants who have composite seroprotection, defined as achieving an hSBA titer ≥ LLOQ- Lower limit of quantification (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all 4 primary MenB test strains combined (composite)
Time frame
Baseline, 28 days post-vaccination3
Percentage of participants achieving seroresponse
Percentage of participants achieving seroresponse, defined as ≥4-fold rise in hSBA titer
Time frame
Baseline to 28 days post-vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov