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Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age (B1971042)

Primary Purpose

Meningitis, Meningococcal, Serogroup B

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rLP2086
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal, Serogroup B

Eligibility Criteria

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

Inclusion Criteria:

  1. Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
  2. Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
  3. Negative urine pregnancy test.

Exclusion Criteria:

  1. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  2. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
  3. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  4. Current chronic use of systemic antibiotics.
  5. Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
  6. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  7. Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
  8. History of microbiologically proven disease caused by Neisseria meningitidis.

Sites / Locations

  • Frontage Clinical Services (Formally ABR)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rLP2086

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Percentage of Participants With at Least One Adverse Event (AE)

Secondary Outcome Measures

Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level

Full Information

First Posted
January 8, 2013
Last Updated
November 30, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01768117
Brief Title
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
Acronym
B1971042
Official Title
A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal, Serogroup B

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rLP2086
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
rLP2086
Intervention Description
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Primary Outcome Measure Information:
Title
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Time Frame
1 month after vaccination 3
Title
Percentage of Participants With at Least One Adverse Event (AE)
Time Frame
Vaccination 1 up to 1 month after Vaccination 3
Secondary Outcome Measure Information:
Title
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ
Time Frame
1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3
Title
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined
Time Frame
1 month after vaccination 3
Title
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Time Frame
1 month after vaccination 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. Male or female subject aged ≥18 to ≤65 years at the time of enrollment. Negative urine pregnancy test. Exclusion Criteria: Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study. Significant neurological disorder or history of seizure (excluding simple febrile seizure). Current chronic use of systemic antibiotics. Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens. History of microbiologically proven disease caused by Neisseria meningitidis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Frontage Clinical Services (Formally ABR)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35164991
Citation
Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Results Reference
derived

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Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

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