Immunogenicity, safety, and tolerability of the meningococcal serogroup B bivalent rLP2086 vaccine in adult laboratory workers. Issue 6 (3rd February 2016)

• Record Type: Journal Article
• Authors: Reiner, David M.; Bhuyan, Prakash; Eiden, Joseph J.; Ginis, John; Harris, Shannon; Jansen, Kathrin U.; Jiang, Qin; Jones, Thomas R.; O'Neill, Robert E.; York, Laura J.; Perez, John L.
• Is Part Of: Vaccine. Volume 34:Issue 6(2016)
• Page Start: 809
• Page End: 813
• Publication Date: 2016-02-03
• Subjects: Neisseria meningitidis -- Serogroup B -- Vaccine -- Meningococcal disease -- Bivalent rLP2086 -- Laboratory worker; ACIP Advisory Committee on Immunization Practices -- AE adverse event -- CI confidence interval -- fHBP factor H binding protein -- GMT geometric mean titer -- hSBA serum bactericidal assay using human complement -- LLOQ lower limit of quantitation -- LP2086 meningococcal lipoprotein 2086, also known as factor H binding protein -- MnB Neisseria meningitidis serogroup B -- SAE serious adverse event; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2015.12.016
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Scientists handling Neisseria meningitidis are at increased risk for meningococcal disease. Bivalent rLP2086 vaccination should protect against N. meningitidis serogroup B. Vaccine immunogenicity, safety were tested in laboratory workers 24–62 years old. Vaccination elicited protective immune responses against 4 diverse MnB strains. These results support bivalent rLP2086 vaccination in this at-risk population. 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.