title: Combined administration of meningococcal serogroup B outer membrane vesicle vaccine and conjugated serogroup C vaccine indicated for prevention of meningococcal disease is safe and immunogenic.
abstract: MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluate safety and immunogenicity of the combination (MenB/C) of the lyophilized active components of the conjugated group C vaccine Menjugate when reconstituted with the full liquid group B outer membrane vesicle vaccine MenBvac compared to MenBvac and Menjugate given separately. At 6-week intervals, healthy adults were given one dose of MenB/C followed by two doses of MenBvac (MenB/C group), three doses of MenBvac (MenB group), or one dose of Menjugate and two doses of placebo (MenC group). Injection site reactions were frequent in all groups. However, most reactions were short lasting and mild or moderate in intensity, and the vaccines were found to be well tolerated, with no vaccine-related serious adverse events. MenB/C was immunogenic with regard to both serogroup B and C meningococci. Both the serum bactericidal assay and the enzyme-linked immunosorbent assay analyses showed that the immune responses of the combination vaccine were similar to the immune responses of its separate components MenBvac and Menjugate for both serogroup B and C. In conclusion, the combined MenB/C vaccine is safe and immunogenic. The two vaccines do not interact negatively with each other and can easily be administered in the same syringe. The induced immune responses suggest that the combined vaccine is likely to confer protection against systemic group B disease caused by the vaccine strain as well as against group C meningococcal disease.
authors.affiliation: Division of Infectious Disease Control, Norwegian Institute of Public Health, P.O. Box 4404 Nydalen, NO-0403 Oslo, Norway. Ingeborg.Aaberge@fhi.no
authors.forename: Ingeborg S
authors.initials: IS
authors.lastname: Aaberge
authors.forename: Philipp
authors.initials: P
authors.lastname: Oster
authors.forename: Oddveig S
authors.initials: OS
authors.lastname: Helland
authors.forename: Anne-Cathrine
authors.initials: AC
authors.lastname: Kristoffersen
authors.forename: Ellen
authors.initials: E
authors.lastname: Ypma
authors.forename: E Arne
authors.initials: EA
authors.lastname: Høiby
authors.forename: Berit
authors.initials: B
authors.lastname: Feiring
authors.forename: Hanne
authors.initials: H
authors.lastname: Nøkleby
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D001425:Bacterial Outer Membrane Proteins; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate