Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models

The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We...

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Main Authors: Yuntao Zhang, Yancen Guo, Yuan Dong, Yingwei Liu, Yuxiu Zhao, Shouzhi Yu, Shihui Li, Chongyang Wu, Baifeng Yang, Wanli Li, Xiaoli Wei, Yadan Zhang, Yunchao Huang, Hui Wang, Xiaoming Yang
Format: Article
Language:English
Published: Taylor & Francis Group 2022-12-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2022.2160158
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author Yuntao Zhang
Yancen Guo
Yuan Dong
Yingwei Liu
Yuxiu Zhao
Shouzhi Yu
Shihui Li
Chongyang Wu
Baifeng Yang
Wanli Li
Xiaoli Wei
Yadan Zhang
Yunchao Huang
Hui Wang
Xiaoming Yang
author_facet Yuntao Zhang
Yancen Guo
Yuan Dong
Yingwei Liu
Yuxiu Zhao
Shouzhi Yu
Shihui Li
Chongyang Wu
Baifeng Yang
Wanli Li
Xiaoli Wei
Yadan Zhang
Yunchao Huang
Hui Wang
Xiaoming Yang
author_sort Yuntao Zhang
collection DOAJ
description The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We used 40 mice and 46 cynomolgus monkeys to evaluate acute and long-term toxicity. Thirty-six guinea pigs were used for sensitization assessment. For immunogenicity assessment, 50 NIH mice and 50 rats were equally randomized to receive 3 doses of 3 different batches of the tested vaccine at an interval of 21 d, or physiological saline solution (0.5 mL). Orbital blood was collected at an interval of 21 d post inoculation to detect related antibody titers or neutralizing antibody titers against poliovirus. Gross autopsy and histopathological examination revealed no abnormal toxicity or irritation in mice and cynomolgus monkeys. Sensitization assessment in guinea pigs indicated the lack of evident allergic symptoms in the high- and low-dose vaccine groups within 30 min after repeated stimulation. The DTacP-sIPV-Hib combination vaccine induced significant immune responses in mice, rats, and cynomolgus monkeys, with 100% seroconversion rates after 3 doses. The DTacP-sIPV-Hib combination vaccine is safe and immunogenic in animal models. Three doses of the vaccine elicited satisfactory antibody responses in mice, rats, and cynomolgus monkeys.
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spelling doaj.art-e12a58a1412f4d3eb2d5f2829f57fbcb2023-09-26T13:25:47ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-12-0118710.1080/21645515.2022.21601582160158Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal modelsYuntao Zhang0Yancen Guo1Yuan Dong2Yingwei Liu3Yuxiu Zhao4Shouzhi Yu5Shihui Li6Chongyang Wu7Baifeng Yang8Wanli Li9Xiaoli Wei10Yadan Zhang11Yunchao Huang12Hui Wang13Xiaoming Yang14China National Biotec Group Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedBeijing Institute of Biological Products Company LimitedChina National Biotec Group Company LimitedThe DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We used 40 mice and 46 cynomolgus monkeys to evaluate acute and long-term toxicity. Thirty-six guinea pigs were used for sensitization assessment. For immunogenicity assessment, 50 NIH mice and 50 rats were equally randomized to receive 3 doses of 3 different batches of the tested vaccine at an interval of 21 d, or physiological saline solution (0.5 mL). Orbital blood was collected at an interval of 21 d post inoculation to detect related antibody titers or neutralizing antibody titers against poliovirus. Gross autopsy and histopathological examination revealed no abnormal toxicity or irritation in mice and cynomolgus monkeys. Sensitization assessment in guinea pigs indicated the lack of evident allergic symptoms in the high- and low-dose vaccine groups within 30 min after repeated stimulation. The DTacP-sIPV-Hib combination vaccine induced significant immune responses in mice, rats, and cynomolgus monkeys, with 100% seroconversion rates after 3 doses. The DTacP-sIPV-Hib combination vaccine is safe and immunogenic in animal models. Three doses of the vaccine elicited satisfactory antibody responses in mice, rats, and cynomolgus monkeys.http://dx.doi.org/10.1080/21645515.2022.2160158safetyimmunogenicitydtacp-sipv-hib vaccineanimal model
spellingShingle Yuntao Zhang
Yancen Guo
Yuan Dong
Yingwei Liu
Yuxiu Zhao
Shouzhi Yu
Shihui Li
Chongyang Wu
Baifeng Yang
Wanli Li
Xiaoli Wei
Yadan Zhang
Yunchao Huang
Hui Wang
Xiaoming Yang
Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
Human Vaccines & Immunotherapeutics
safety
immunogenicity
dtacp-sipv-hib vaccine
animal model
title Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
title_full Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
title_fullStr Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
title_full_unstemmed Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
title_short Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models
title_sort safety and immunogenicity of a combined dtacp sipv hib vaccine in animal models
topic safety
immunogenicity
dtacp-sipv-hib vaccine
animal model
url http://dx.doi.org/10.1080/21645515.2022.2160158
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