Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity

Chankyu Lee; Seuk Keun Choi; Rock Ki Kim; Heeyoun Kim; Yoon Hee Whang; Huyen Pharm; Hyunwoo Cheon; Do Young Yoon; Chan Wha Kim; Yeong Ok Baik; Sung Soo Park; Inhwan Lee

doi:10.1016/j.biologicals.2019.07.005

Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity

Chankyu Lee, Seuk Keun Choi, Rock Ki Kim, Heeyoun Kim, Yoon Hee Whang, Huyen Pharm, Hyunwoo Cheon, Do Young Yoon, Chan Wha Kim, Yeong Ok Baik, Sung Soo Park, Inhwan Lee

Research output: Contribution to journal › Article › peer-review

11 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	32-37
Number of pages	6
Journal	Biologicals
Volume	61
DOIs	https://doi.org/10.1016/j.biologicals.2019.07.005
Publication status	Published - 2019 Sept

Bibliographical note

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

Keywords

Enzyme-linked immunosorbent assay
Immunogenicity
Opsonophagocytic activity
Polyvalent pneumococcal conjugate vaccine

ASJC Scopus subject areas

Biotechnology
Bioengineering
Applied Microbiology and Biotechnology
General Immunology and Microbiology
Pharmacology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.biologicals.2019.07.005

Cite this

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title = "Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity",

abstract = "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{\textregistered}. Among the shared serotypes in both PCV15 and Prevnar13{\textregistered}, Type 3 and 23F in PCV15 exhibited a lower opsonic index than Prevnar13{\textregistered}. 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.",

keywords = "Enzyme-linked immunosorbent assay, Immunogenicity, Opsonophagocytic activity, Polyvalent pneumococcal conjugate vaccine",

author = "Chankyu Lee and Choi, {Seuk Keun} and Kim, {Rock Ki} and Heeyoun Kim and Whang, {Yoon Hee} and Huyen Pharm and Hyunwoo Cheon and Yoon, {Do Young} and Kim, {Chan Wha} and Baik, {Yeong Ok} and Park, {Sung Soo} and Inhwan Lee",

note = "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: {\textcopyright} 2019 International Alliance for Biological Standardization",

year = "2019",

month = sep,

doi = "10.1016/j.biologicals.2019.07.005",

language = "English",

volume = "61",

pages = "32--37",

journal = "Biologicals",

issn = "1045-1056",

publisher = "Academic Press",

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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

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DO - 10.1016/j.biologicals.2019.07.005

M3 - Article

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AN - SCOPUS:85070502469

SN - 1045-1056

VL - 61

SP - 32

EP - 37

JO - Biologicals

JF - Biologicals

ER -

Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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