A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: Results of a randomised, controlled, dose-escalation phase 1 trial

Highlights ► A first-in-human study of a bivalent rLP2086 N. meningitidis serogroup B vaccine. ► Healthy adults received placebo or ascending dose levels of bivalent rLP2086. ► Bivalent rLP2086 induced robust serum bactericidal activity against 6 diverse MnB strains. ► Most recipients (75–100%) of 6...

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Veröffentlicht in:	Vaccine 2012-09, Vol.30 (43), p.6163-6174
Hauptverfasser:	Richmond, P.C, Nissen, M.D, Marshall, H.S, Lambert, S.B, Roberton, D, Gruber, W.C, Jones, T.R, Arora, A
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Allergy and Immunology antibacterial properties antibodies Antibodies, Bacterial - blood Antigens, Bacterial - immunology Bacterial outer membrane proteins Bacterial Proteins - immunology Bactericidal activity Bactericidal antibodies, Factor H binding protein binding proteins blood serum complement Complement factor H Complement System Proteins - immunology Double-Blind Method Female Humans immune response Immunogenicity Immunoglobulin G Immunoglobulin G - blood Lipoproteins Male Meningitis Meningococcal Infections - prevention & control Meningococcal vaccines Meningococcal Vaccines - administration & dosage Meningococcal Vaccines - adverse effects Meningococcal Vaccines - immunology Neisseria meningitidis Neisseria meningitidis serogroup B Neisseria meningitidis, Serogroup B - immunology septicemia serotypes Serum Bactericidal Antibody Assay Vaccination Vaccines Vaccines, Synthetic - administration & dosage Vaccines, Synthetic - adverse effects Vaccines, Synthetic - immunology Young Adult young adults
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Beschreibung
Zusammenfassung:	Highlights ► A first-in-human study of a bivalent rLP2086 N. meningitidis serogroup B vaccine. ► Healthy adults received placebo or ascending dose levels of bivalent rLP2086. ► Bivalent rLP2086 induced robust serum bactericidal activity against 6 diverse MnB strains. ► Most recipients (75–100%) of 60 μg or 200 μg doses had seroprotective (≥1:4) hSBA titres. ► The vaccine was well tolerated; adverse events were rare and generally mild or moderate.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2012.07.065