Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Completed · Phase 4
Conditions studied: Meningococcal Infections
In brief
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.
Key facts
- Study ID
- NCT02569632
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 18
- Starts
- 2015-01-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2021-02-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
- University of Massachusetts Medical School — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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