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Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)

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ClinicalTrials.gov Identifier: NCT02569632
Recruitment Status : Unknown
Verified October 2015 by UCSF Benioff Children’s Hospital Oakland.
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
UCSF Benioff Children’s Hospital Oakland

Brief 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.

Condition or disease Intervention/treatment Phase
Meningococcal Infections Biological: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) Phase 4

Detailed Description:
Neisseria meningitidis causes meningitis and severe infections of the blood stream. The incidence of serogroup B meningococcal disease however is too low to conduct a randomized, controlled trial to determine the actual efficacy of the new serogroup B vaccines. Instead vaccine efficacy was inferred from serum bactericidal antibody responses using four test strains. However, because of strain variability of FHbp amino acid sequence (there are more than 800 sequence variants described) and strain variability of FHbp expression, bactericidal data on only four strains are unlikely to be sufficient to predict the actual strain coverage by the vaccine. There also are gaps in knowledge about the underlying mechanisms by which human antibodies to FHbp elicit complement mediated bactericidal activity. For example, binding of FH to FHbp is specific for human FH. Therefore in vaccinated humans the vaccine antigen is expected to form a complex with FH right after immunization. The investigators' hypothesis is that binding of human FH to the vaccine antigen skews the antibody repertoire to FHbp epitopes located outside of the FH combining site. The resulting antibodies would be expected not to inhibit binding of FH to the bacteria. This hypothesis will be investigated in Trumenba-immunized humans as part of studies in Aim 1 (and in future studies of recombinant human anti-FHbp Fabs that will be enabled by obtaining DNA from individual B cells, described in Aim 2).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : January 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: Open Label: MenB-FHbp
Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)
Biological: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)
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.
Other Name: MenB-FHbp




Primary Outcome Measures :
  1. Breadth of protective activity of serum anti-FHbp antibody responses of adults immunized with Trumenba vaccine as assessed by serum bactericidal titers [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Antibody repertoire to FHbp [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569632


Locations
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United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
UCSF Benioff Children’s Hospital Oakland
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Dan Granoff, MD Children's Hospital Oakland Research Institute, Center for Immunobiology and Vaccine Development

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCSF Benioff Children’s Hospital Oakland
ClinicalTrials.gov Identifier: NCT02569632     History of Changes
Other Study ID Numbers: ChildrensHRCOakland
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: October 2015
Keywords provided by UCSF Benioff Children’s Hospital Oakland:
Meningococcal Vaccines
Neisseria Meningitidis
Factor H-binding Protein
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs