David M Reiner1, Prakash Bhuyan2, Joseph J Eiden3, John Ginis4, Shannon Harris5, Kathrin U Jansen6, Qin Jiang7, Thomas R Jones8, Robert E O'Neill9, Laura J York10, John L Perez11. 1. Frontage Clinical Research Center, 241 Main Street, 3rd Floor, Hackensack, NJ 07601, USA. Electronic address: David.reiner@bayer.com. 2. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: Prakash.Bhuyan@pfizer.com. 3. Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: joseph.eiden@pfizer.com. 4. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: john.ginis@pfizer.com. 5. Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: Shannon.Harris@pfizer.com. 6. Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: kathrin.jansen@pfizer.com. 7. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: qin.jiang@pfizer.com. 8. Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: thomas.r.jones@pfizer.com. 9. Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: robert.oneill@pfizer.com. 10. Pfizer Medical and Scientific Affairs, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: laura.york@pfizer.com. 11. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: john.perez@pfizer.com.
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.
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.
Authors: Robert G K Donald; Julio Cesar Hawkins; Li Hao; Paul Liberator; Thomas R Jones; Shannon L Harris; John L Perez; Joseph J Eiden; Kathrin U Jansen; Annaliesa S Anderson Journal: Hum Vaccin Immunother Date: 2016-12-14 Impact factor: 3.452