Phase 4
Completed N=18
Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Meningococcal Infections
Source: ClinicalTrials.gov NCT02569632 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers — 93 percentage of participants
◆ Published Evidence
Established
26citations · ~3 / year
Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine.
Summary
This study will investigate the breadth of protection against meningococcal disease in humans immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®" manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated bactericidal activity.
Linked Publications
-
Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers |
93 | — |
| SECONDARY Antibody Repertoire to FHbp |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adults in the following risk groups: physicians, nurses, respiratory therapists, microbiology laboratory personnel working at UCSF Benioff Children's Hospital Oakland or the University of Massachusetts Medical School as well as medical students attending accredited U.S. medical schools
- Able to comprehend and follow all required study procedures
- In good health as determined by a brief medical history
- For females of child bearing age a negative urine pregnancy test will be required
Exclusion Criteria
- Are not in the risk groups summarized above
- Have not given or are unable to give written informed consent to participate in the study
- Females of child bearing potential who are pregnant, or planning on becoming pregnant during the study period.
- Persons with a past history of having Guillain-Barré Syndrome (GBS), or a family history of GBS in a parent or sibling.
- Persons with presence or suspected presence of serious chronic disease including but not limited to: chronic cardiac disease, autoimmune disease, diabetes, hepatitis B/C, HIV, progressive neurological disease or seizure, leukemia, lymphomas, or neoplasm.
- Have participated in any other investigational drug or received any other vaccine within the last 30 days.
- Received a dose of a meningococcal serogroups A, C, Y, W conjugate vaccine within the previous 30 days or wish to receive a dose of this vaccine during the six month study period.
- Have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous dose of Trumenba
- Have experienced fever (oral temperature above 38.0°C) within the past 3 days or are suffering from a present acute infectious disease
- Are planning to leave the area of the study site before the end of the study period
- Have obesity (BMI higher than 33); or 11.
- With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Data sourced from ClinicalTrials.gov (NCT02569632) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.