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

Phase 2

Completed

• Conditions: Meningitis, Meningococcal, Serogroup B
• Interventions: Biological: rLP2086

• Registration Number: NCT01768117
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-02-23
• Results First Submitted QC: 2015-02-23
• Results First Posted: 2015-03-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rLP2086	rLP2086	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Adverse Event (AE)	Vaccination 1 up to 1 month after Vaccination 3
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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level	1 month after vaccination 3
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

Trial Locations

Locations (1)

Frontage Clinical Services (Formally ABR); 🇺🇸 Hackensack, New Jersey, United States