Original Article
Safety and immunogenicity evaluation of 13-valent pneumococcal conjugate vaccine in mice
Jing Ti, Tingting Wang, Zherong You, Xiao Duan, Yingfeng He, Minghua Zhang, Xiuli Tang
Published 2017-02-10
Cite as Int J Biologicals, 2017, 40(1): 5-8. DOI: 10.3760/cma.j.issn.1673-4211.2017.01.002
Abstract
ObjectiveTo evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine (PCV-13) in mice.
MethodsNinety mice were simply randomized into 3 groups and immunized with PCV-13, commercial 7-valent pneumococcal conjugate vaccine (PCV-7), and saline, respectively. Three subcutaneous injections were given on 0, 14 and 28 d. Mice weight and state changes were observed for 35 days since first injection. Ten mice per group were randomly taken for eye blood sampling on 14 d, and the remaining 20 were sampled on 35 d. Sera were then separated and preserved under -40 ℃. ELISA was performed on serum samples to detect IgG antibody levels against each serotype pneumococcal capsular polysaccharide included in PCV-13.
ResultsPCV-13 had no untoward effect on mice weight gain or other physical state, showing good safety. After 3 immunizations, antibody concentration against every serotype polysaccharide increased, suggesting potent immunogenicity of the vaccine. Compared with commercial PCV-7, PCV-13 presented similar immunogenicity toward all 7 mutual serotypes (t=0.004, P﹥0.05).
ConclusionThe PCV-13 tested has good safety and immunogenicity in mice and this provides certain theoretical basis for the preclinical study of this vaccine.
Key words:
Pneumococcal vaccines; Streptococcus pneumoniae; Vaccines, conjugate; Safety; Immunogenicity
Contributor Information
Jing Ti
R&
D Center, Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China
Tingting Wang
Zherong You
Xiao Duan
Yingfeng He
Minghua Zhang
Xiuli Tang