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

Meningitis, Meningococcal, Serogroup B Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768117
• Other study ID #: B1971042
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningitis, Meningococcal, Serogroup B

Intervention

Biological:
• rLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months

Locations

Country	Name	City	State
United States	Frontage Clinical Services (Formally ABR)	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants With at Least One Adverse Event (AE)		Vaccination 1 up to 1 month after Vaccination 3
Secondary	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
Secondary	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
Secondary	Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level		1 month after vaccination 3