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Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea.

Authors
 Dong Soo Kim  ;  Min Ja Kim  ;  Sung-Ho Cha  ;  Hwang Min Kim  ;  Jong-Hyun Kim  ;  Kwang Nam Kim  ;  Jin-Soo Lee  ;  Jun Yong Choi  ;  Valerie Bosch Castells  ;  Hee Soo Kim  ;  Joon Bang  ;  Philipp Oster 
Citation
 INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, Vol.45 : 59-64, 2016 
Journal Title
 INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES 
ISSN
 1201-9712 
Issue Date
2016
MeSH
Adolescent ; Adult ; Antibodies, Bacterial/blood ; Child ; Female ; Humans ; Male ; Meningococcal Vaccines/adverse effects ; Meningococcal Vaccines/immunology* ; Middle Aged ; Republic of Korea ; Seroconversion ; Serogroup ; Vaccination ; Vaccines, Conjugate/immunology ; Young Adult
Keywords
Immunogenicity ; MenACYW–D ; Meningococcal vaccine ; Republic of Korea ; Safety
Abstract
OBJECTIVES: To assess the safety and immunogenicity of a meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) in a Korean population. METHODS: This was a phase III, blind-observer, controlled study in which participants aged 11-55 years were randomized (2:1 ratio) to a single dose of MenACYW-D or tetanus/diphtheria/acellular pertussis (Tdap) vaccine. Outcomes included rates of seroconversion against all serogroups (≥4-fold increase in antibody titer from pre-vaccination), geometric mean titers (GMTs) at days 0 and 28 based on a serum bactericidal assay using baby rabbit complement, rates of seroprotection (titer ≥1:128) at day 28, and safety. RESULTS: A total of 300 participants were enrolled in the study (200 MenACYW-D and 100 Tdap). Seroconversion rates for serogroups A, C, Y, and W-135 were 77.8%, 88.3%, 74.6%, and 92.4%, respectively, for the MenACYW-D group and 9.3%, 8.1%, 12.2%, and 8.2%, respectively, for the Tdap group. The proportions of participants with pre-vaccination titers ≥1:128 were 57.3%, 12.6%, 51.5%, and 22.2% for serogroups A, C, Y, and W-135, respectively; post-vaccination rates were 98.5%, 89.4%, 96.0%, and 95.0% for the MenACYW-D group. A lower proportion of participants reported solicited reactions with MenACYW-D (46.2%) compared with Tdap (76.8%). CONCLUSION: A single dose of MenACYW-D was well tolerated and elicited a robust immune response in Korean adolescents and adults.
Full Text
http://www.sciencedirect.com/science/article/pii/S1201971216000308
DOI
10.1016/j.ijid.2016.02.010
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Dong Soo(김동수)
Choi, Jun Yong(최준용) ORCID logo https://orcid.org/0000-0002-2775-3315
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/146701
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