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

Primary Purpose

Meningococcal Infections

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)

About this trial

This is an interventional other trial for Meningococcal Infections focused on measuring Meningococcal Vaccines, Neisseria Meningitidis, Factor H-binding Protein

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UCSF Benioff Children's Hospital Oakland
University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label: MenB-FHbp

Arm Description

Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02569632

First Posted

September 30, 2015

Last Updated

February 1, 2021

Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

University of Massachusetts, Worcester

1. Study Identification

Unique Protocol Identification Number

NCT02569632

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Infections

Keywords

Meningococcal Vaccines, Neisseria Meningitidis, Factor H-binding Protein

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label: MenB-FHbp

Arm Type

Experimental

Arm Description

Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals)

Intervention Type

Biological

Intervention Name(s)

Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)

Other Intervention Name(s)

MenB-FHbp

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.

Primary Outcome Measure Information:

Title

Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers

Description

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Antibody Repertoire to FHbp

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Granoff, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Benioff Children's Hospital Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

University of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28566335

Citation

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.

Results Reference

result

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

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