Phase 4
N=18
Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT02569632 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- Dec 2016
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 |
— | — |
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.
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). 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.