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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01768117
First received: January 8, 2013
Last updated: February 23, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Meningitis, Meningococcal, Serogroup B
Biological: rLP2086
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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) [ Time Frame: 1 month after vaccination 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level [ Time Frame: 1 month after vaccination 3 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086 Biological: rLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768117

Locations
United States, New Jersey
Frontage Clinical Services (Formally ABR)
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01768117     History of Changes
Other Study ID Numbers: B1971042 
Study First Received: January 8, 2013
Results First Received: February 23, 2015
Last Updated: February 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections

ClinicalTrials.gov processed this record on August 24, 2016