Immunogenicity, safety, and tolerability of the meningococcal serogroup B bivalent rLP2086 vaccine in adult laboratory workers

Vaccine. 2016 Feb 3;34(6):809-13. doi: 10.1016/j.vaccine.2015.12.016. Epub 2015 Dec 19.

Abstract

Background: The bivalent rLP2086 vaccine is approved in the United States to prevent meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10-25 years. The immunogenicity and safety of bivalent rLP2086 were evaluated in microbiologists 24-62 years old who handle MnB.

Methods: Seven subjects vaccinated at 0, 2, and 6 months had functional antibodies measured before vaccination and 1 month after each dose by serum bactericidal assays using human complement (hSBAs) and 4 vaccine-heterologous MnB test strains.

Results: Six subjects qualified for analysis. All demonstrated hSBA titers ≥the lower limit of quantitation (LLOQ) against 3 of 4 strains; 3 subjects achieved titers ≥LLOQ for the fourth. Safety-related events following vaccination were generally mild to moderate in severity.

Conclusions: Three doses of bivalent rLP2086 were generally well tolerated in laboratory personnel and elicited protective functional immune responses reflective of broad coverage against MnB disease.

Keywords: Bivalent rLP2086; Laboratory worker; Meningococcal disease; Neisseria meningitidis; Serogroup B; Vaccine.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Female
  • Humans
  • Immunization Schedule
  • Laboratory Personnel*
  • Male
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / therapeutic use*
  • Middle Aged
  • Neisseria meningitidis, Serogroup B
  • Safety
  • Serum Bactericidal Test

Substances

  • Antibodies, Bacterial
  • Meningococcal Vaccines