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

NCT02569632 | Completed Phase 4 Results

• 1 other identifier: ChildrensHRCOakland
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Meningococcal Infections

Keywords

Meningococcal Vaccines; Neisseria Meningitidis; Factor H-binding Protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Antibody Repertoire to FHbp

  1 year

Study Arms (1)

Open Label: MenB-FHbp

EXPERIMENTAL

Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)

Biological: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)

Interventions

Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) BIOLOGICAL

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.

Also known as: MenB-FHbp

Open Label: MenB-FHbp

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• University of Massachusetts, Worcester: collaborator

Study Sites (2)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• 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):e00121-17. doi: 10.1128/CVI.00121-17. Print 2017 Aug.

  PMID: 28566335 RESULT

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenB-FHbp vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dan Granoff, MD (Principal Investigator)
• Organization: Children's Hospital Oakland Research Institute (CHORI)

dgranoff@chori.org

510-428-3000

Study Officials

• Dan Granoff, MD

  Children's Hospital Oakland Research Institute, Center for Immunobiology and Vaccine Development

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)