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Clin Exp Pediatr > Accepted Articles
DOI: https://doi.org/10.3345/cep.2019.01067    [Accepted]
Published online November 22, 2019.
Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6 to 10 weeks : a randomized, double blind, active-controlled trial
Jonghoon Shin1  , Jamaree Teeratakulpisarn2  , Thanyawee Puthanakit3  , Tuangtip Theerawit3  , Ji Hwa Ryu1  , Jinhwan Shin1  , Seulgi Lee1  , Hayoung Lee1  , Kyungjun An1  , Hun Kim1 
1SK bioscience, Seonam-si, Republic of Korea
2Department of Pediatrics, Khon Kaen University, Khon Kaen, Thailand
3Department of Pediatrics and Center of Excellence in Pediatric Infectious Diseases and Vaccine Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Correspondence: 
Hun Kim, Tel: +82-2-2008-3920, Fax: +82-2-2008-2047, Email: ebolakim@sk.com
Received: 6 September 2019   • Revised: 21 November 2019   • Accepted: 22 November 2019
Abstract
Background
Pneumococcal diseases are associated with high annual mortality rate among children aged under 5 years worldwide. GBP411 is a 12-valent pneumococcal conjugate vaccine.
Purpose
This study aimed to evaluate GBP411’s immunogenicity and safety with a dosing schedule of 2 primary doses plus 1 booster dose (2p + 1) administered to healthy infants.
Methods
In this randomized, active-controlled (Prevnar 13®), double-blind, phase 2 trial, subjects were eligible if they were aged 6–10 weeks and healthy. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.
Results
After the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations > 0.35 µg/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% versus 39.22%, P = 0.0467; 19A: 58.33% versus 90.20%, P = 0.0003). After the booster dose, however, >97% of the subjects in each group achieved IgG concentrations ≥ 0.35 µg/mL for all 12 serotypes. An increased immunogenicity was noted for some serotypes for which there were significant intergroup differences after the primary doses; the intergroup differences were not significant for all 12 serotypes after the booster dose. With regard to safety, there was no significant difference in the overall incidence of solicited local adverse events between the groups; further, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% versus 98.04%, P = 0.0032).
Conclusion
GBP411 with a dosing schedule of 2p + 1 may be immunogenic and safe for healthy infants.
Key Words: 12-Valent pneumococcal conjugate vaccine, Streptococcus pneumoniae, Immunogenicity, Safety, Infant




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