Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)
Intervention description: All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal Vaccines; Neisseria Meningitidis; Factor H-binding Protein

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.