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: March 17, 2014
Last verified: March 2014
  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:
  • Proportion of subjects with titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary test strains at 1 month after the third vaccination with bivalent rLP2086 vaccine. [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
  • Percentage of subjects reporting local reactions and systemic events for 7 days after each vaccination visit. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting the use of antipyrectic medication for 7 days after each vaccination visit [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 SAE 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccination and during the vaccination phase. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting at least 1 immediate AE after each vaccination. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Subject's days missing school or work due to AEs during the vaccination phase [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains 1 month after the first vaccination with bivalent rLP2086 vaccine. [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
  • Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains 1 month after the second vaccination with bivalent rLP2086 vaccine. [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains immediately prior to the third vaccination with bivalent rLP2086 vaccine. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving an hSBA titer ≥ lower limit of quantitation (LLOQ) for all 4 primary test strains combined, 1 month after the third vaccination with bivalent rLP2086 vaccine [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains [ Time Frame: 7 Months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: January 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768117

Locations
United States, New Jersey
Pfizer Investigational Site
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01768117     History of Changes
Other Study ID Numbers: B1971042
Study First Received: January 8, 2013
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014