TY - JOUR
T1 - Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea-randomised trial
AU - Lee, Hoan Jong
AU - Choe, Young June
AU - Hong, Young Jin
AU - Kim, Kyung Hyo
AU - Park, Su Eun
AU - Kim, Yun Kyung
AU - Oh, Chi Eun
AU - Lee, Hyunju
AU - Song, Hyoyoung
AU - Bock, Hans
AU - Casula, Daniela
AU - Bhusal, Chiranjiwi
AU - Arora, Ashwani Kumar
N1 - Publisher Copyright:
© 2016 Elsevier Ltd.
PY - 2016/2/24
Y1 - 2016/2/24
N2 - Background: Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents. Methods: 264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed. Results: One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs. Conclusions: Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).
AB - Background: Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents. Methods: 264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed. Results: One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs. Conclusions: Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).
KW - 4CMenB vaccine
KW - Adolescents
KW - Korea
KW - Neisseria meningitidis
KW - Serogroup B
UR - http://www.scopus.com/inward/record.url?scp=84958073281&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2016.01.033
DO - 10.1016/j.vaccine.2016.01.033
M3 - Article
C2 - 26826544
AN - SCOPUS:84958073281
SN - 0264-410X
VL - 34
SP - 1180
EP - 1186
JO - Vaccine
JF - Vaccine
IS - 9
ER -