Meningococcal Infections Clinical Trial
Official title:
Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba) in Adults at Increased Risk of Meningococcal Disease Because of Occupational Exposure
Verified date | February 2021 |
Source | UCSF Benioff Children's Hospital Oakland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
United States | University of Massachusetts Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
UCSF Benioff Children's Hospital Oakland | University of Massachusetts, Worcester |
United States,
Lujan E, Partridge E, Giuntini S, Ram S, Granoff DM. Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine. Clin Vaccine Immunol. 2017 Aug 4;24(8). pii: e00121-17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers | Determine the percentage of subjects achieving serum bactericidal titers of 1:4 or greater in serum obtained 1 month after doses 2 and 3 as measured against a panel of 15 genetically diverse meningococcal strains. | 18 months | |
Secondary | Antibody Repertoire to FHbp | Determine the percentage of recombinant anti-FHbp Fabs isolated from B cells of each subject that react with 3 FHbp amino acid sequence variants representative of FHbp variant groups 1, 2 and 3 | 1 year |
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