TY - JOUR
T1 - Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity
AU - Lee, Chankyu
AU - Choi, Seuk Keun
AU - Kim, Rock Ki
AU - Kim, Heeyoun
AU - Whang, Yoon Hee
AU - Pharm, Huyen
AU - Cheon, Hyunwoo
AU - Yoon, Do Young
AU - Kim, Chan Wha
AU - Baik, Yeong Ok
AU - Park, Sung Soo
AU - Lee, Inhwan
N1 - Funding Information:
This study was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI14C2711 ).
Funding Information:
This study was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI14C2711).
Publisher Copyright:
© 2019 International Alliance for Biological Standardization
PY - 2019/9
Y1 - 2019/9
N2 - A new 15-valent pneumococcal conjugate vaccine (PCV15) against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 11A, 14, 18C, 19A, 19F, 22F, and 23F has been developed using aluminum phosphate as an adjuvant. Using the rabbit model, immunogenicity of each serotype was evaluated by measuring antigen specific antibodies and functional antibody titers and comparing them to a control vaccine, Prevnar13®. Among the shared serotypes in both PCV15 and Prevnar13®, Type 3 and 23F in PCV15 exhibited a lower opsonic index than Prevnar13®. Conversely, the other types showed greater or nearly the same immunogenic effects. Type 11A and 22F are two additional serotypes included in PCV15, and only 22F showed a reasonable opsonic index compared with other types. Type 11A exhibited a basal level fold-increase in OPA; thus, we further optimized 11A as well as 3 and 23F by controlling the polysaccharide-to-protein conjugation ratio as a variable. Antibody levels and functional antibody activities were evaluated by ELISA and OPA, and improved levels of immunogenic activities were observed for all three serotypes. In this study, we propose a new PCV15 candidate, in which the common 13 serotypes and a licensed control vaccine have equivalent efficacy while two additional serotypes showed adequate immunogenicity in the rabbit model.
AB - A new 15-valent pneumococcal conjugate vaccine (PCV15) against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 11A, 14, 18C, 19A, 19F, 22F, and 23F has been developed using aluminum phosphate as an adjuvant. Using the rabbit model, immunogenicity of each serotype was evaluated by measuring antigen specific antibodies and functional antibody titers and comparing them to a control vaccine, Prevnar13®. Among the shared serotypes in both PCV15 and Prevnar13®, Type 3 and 23F in PCV15 exhibited a lower opsonic index than Prevnar13®. Conversely, the other types showed greater or nearly the same immunogenic effects. Type 11A and 22F are two additional serotypes included in PCV15, and only 22F showed a reasonable opsonic index compared with other types. Type 11A exhibited a basal level fold-increase in OPA; thus, we further optimized 11A as well as 3 and 23F by controlling the polysaccharide-to-protein conjugation ratio as a variable. Antibody levels and functional antibody activities were evaluated by ELISA and OPA, and improved levels of immunogenic activities were observed for all three serotypes. In this study, we propose a new PCV15 candidate, in which the common 13 serotypes and a licensed control vaccine have equivalent efficacy while two additional serotypes showed adequate immunogenicity in the rabbit model.
KW - Enzyme-linked immunosorbent assay
KW - Immunogenicity
KW - Opsonophagocytic activity
KW - Polyvalent pneumococcal conjugate vaccine
UR - http://www.scopus.com/inward/record.url?scp=85070502469&partnerID=8YFLogxK
U2 - 10.1016/j.biologicals.2019.07.005
DO - 10.1016/j.biologicals.2019.07.005
M3 - Article
C2 - 31416790
AN - SCOPUS:85070502469
VL - 61
SP - 32
EP - 37
JO - Journal of Biological Standardization
JF - Journal of Biological Standardization
SN - 1045-1056
ER -
