PMID- 26826544
OWN - NLM
STAT- MEDLINE
DCOM- 20160929
LR  - 20160219
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 34
IP  - 9
DP  - 2016 Feb 24
TI  - Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine 
      in healthy adolescents in Korea--A randomised trial.
PG  - 1180-6
LID - S0264-410X(16)00077-3 [pii]
LID - 10.1016/j.vaccine.2016.01.033 [doi]
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).
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Lee, Hoan Jong
AU  - Lee HJ
AD  - Seoul National University Children's Hospital, Seoul National College of 
      Medicine, Seoul, South Korea.
FAU - Choe, Young June
AU  - Choe YJ
AD  - Seoul National University Children's Hospital, Seoul National College of 
      Medicine, Seoul, South Korea.
FAU - Hong, Young-Jin
AU  - Hong YJ
AD  - Inha University Hospital, Incheon, South Korea.
FAU - Kim, Kyung-Hyo
AU  - Kim KH
AD  - Ewha Womans University Mokdong Hospital, Seoul, South Korea.
FAU - Park, Su Eun
AU  - Park SE
AD  - Pusan National University Children's Hospital, Yangsan, South Korea.
FAU - Kim, Yun-Kyung
AU  - Kim YK
AD  - Korea University Ansan Hospital, Seoul, South Korea.
FAU - Oh, Chi-Eun
AU  - Oh CE
AD  - Kosin University Gospel Hospital, Busan, South Korea.
FAU - Lee, Hyunju
AU  - Lee H
AD  - Seoul National University Bundang Hospital, Seongnam, South Korea.
FAU - Song, Hyoyoung
AU  - Song H
AD  - GlaxoSmithKline Korea Ltd, Seoul, South Korea.
FAU - Bock, Hans
AU  - Bock H
AD  - Novartis Asia Pacific Pharmaceuticals Ptd Ltd, Singapore, Singapore.
FAU - Casula, Daniela
AU  - Casula D
AD  - Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy.
FAU - Bhusal, Chiranjiwi
AU  - Bhusal C
AD  - Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy. Electronic 
      address: ashwani.k.arora@gsk.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01973218
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160128
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (4CMenB vaccine)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (MenACWY)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
RN  - 9007-36-7 (Complement System Proteins)
SB  - IM
MH  - Adolescent
MH  - Antibodies, Bacterial/blood
MH  - Child
MH  - Complement System Proteins/immunology
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Humans
MH  - Male
MH  - Meningococcal Infections/*prevention & control
MH  - Meningococcal Vaccines/immunology/*therapeutic use
MH  - Neisseria meningitidis, Serogroup B
MH  - Republic of Korea
MH  - Serum Bactericidal Antibody Assay
MH  - Single-Blind Method
MH  - Vaccines, Conjugate/immunology/therapeutic use
OTO - NOTNLM
OT  - 4CMenB vaccine
OT  - Adolescents
OT  - Korea
OT  - Neisseria meningitidis
OT  - Serogroup B
EDAT- 2016/01/31 06:00
MHDA- 2016/09/30 06:00
CRDT- 2016/01/31 06:00
PHST- 2015/07/30 00:00 [received]
PHST- 2016/01/13 00:00 [revised]
PHST- 2016/01/14 00:00 [accepted]
PHST- 2016/01/31 06:00 [entrez]
PHST- 2016/01/31 06:00 [pubmed]
PHST- 2016/09/30 06:00 [medline]
AID - S0264-410X(16)00077-3 [pii]
AID - 10.1016/j.vaccine.2016.01.033 [doi]
PST - ppublish
SO  - Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 
      Jan 28.