Neisseria MeningitidisPhase 4NCT07197762
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
A Phase 4 study testing Trumenba and PENBRAYA in people with Neisseria Meningitidis, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis
- What is being tested?
- Trumenba and PENBRAYA
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica McCaffery, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Emory Children's Center-Vaccine Research Clinic
Atlanta, Georgia, 30329
Christina Rostad, MD, 404-727-2472, Christina.rostad@emory.edu
- Recruiting
Hope Clinic
Atlanta, Georgia, 30329
Christina Rostad, MD, 404-727-2472, Christina.rostad@emory.edu
About this study
Official title: Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
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?
Read the 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:
- Healthy individuals aged 16-23 years when shared clinical decision-making supports MenB vaccination
- 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
- Being tested
- Trumenba, PENBRAYA
- Keywords
- MenACWY-TT/MenB-FHbp [Penbraya, Pfizer], Meningococcus B, MenB-FHbp [Trumenba, Pfizer], Neisseria meningitidis serogroup B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrumenbaBiological
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.
PENBRAYABiological
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 group | Role | What they receive |
|---|---|---|
| Trumenba group | Experimental | Not described Receives: Biological: Trumenba |
| Penbraya group | Experimental | Not described Receives: Biological: PENBRAYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 28 days post-vaccination
Secondary outcomes (3)
human Serum bactericidal antibody (hSBA) quantity
Human serum bactericidal antibody (hSBA) Geometric mean titer will be described for all 4 indicator strains of MenB
Measured: Baseline, 28 days post-vaccination
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)
Measured: Baseline, 28 days post-vaccination
Percentage of participants achieving seroresponse
Percentage of participants achieving seroresponse, defined as ≥4-fold rise in hSBA titer
Measured: Baseline to 28 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start4 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Christina Rostad, Emory University
- Investigators
- Christina Rostad, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197762
- Sponsor's protocol ID
- STUDY00009836
- Other IDs
- 2025P011916
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
- ClinicalTrials.gov ID
- NCT07197762
- Acronym / sponsor ID
- STUDY00009836
- Conditions
- Neisseria Meningitidis
- Keywords
- MenACWY-TT/MenB-FHbp [Penbraya, Pfizer], Meningococcus B, MenB-FHbp [Trumenba, Pfizer], Neisseria meningitidis serogroup B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Healthy individuals aged 16-23 years when shared clinical decision-making supports MenB vaccination
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trumenba group | Experimental | Biological: Trumenba |
| Penbraya group | Experimental | Biological: PENBRAYA |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrumenbaTrumenba 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 | Trumenba group |
| PENBRAYAPENBRAYA 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. | Biological | Penbraya group |
Primary outcome
Percentage of participants who are seroprotected
Time frame: Baseline, 28 days post-vaccination
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.
3 secondary outcomes
human Serum bactericidal antibody (hSBA) quantity
Time frame: Baseline, 28 days post-vaccination
Percentage of participants who have composite seroprotection
Time frame: Baseline, 28 days post-vaccination
Percentage of participants achieving seroresponse
Time frame: Baseline to 28 days post-vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica McCaffery, PhD contact
Christina Rostad, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trumenba and PENBRAYA in people with Neisseria Meningitidis, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Rostad, MD (404-727-2472, Christina.rostad@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who are seroprotected (time frame: Baseline, 28 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.