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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Meningococcal, Serogroup B

Intervention / Treatment
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* Biological: rLP2086


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rLP2086<br> | Biological: rLP2086<br>* 0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) |  | 1 month after vaccination 3 | 
| Percentage of Participants With at Least One Adverse Event (AE) |  | Vaccination 1 up to 1 month after Vaccination 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ |  | 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3 | 
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined |  | 1 month after vaccination 3 | 
| Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level |  | 1 month after vaccination 3 |