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Article

Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China

1
Guangxi Center for Disease Prevention and Control, Nanning 530027, China
2
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd., Beijing 100176, China
3
National Institutes for Food and Drug Control, Beijing 102629, China
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Yongfu Center for Disease Prevention and Control, Guilin 541800, China
5
Yizhou Center for Disease Prevention and Control, Hechi 546399, China
6
Beijing Bacterial Vaccine Engineering Research Centre, Beijing 100176, China
*
Author to whom correspondence should be addressed.
Academic Editors: Duncan Steele and Calman A. MacLennan
Vaccines 2022, 10(1), 33; https://doi.org/10.3390/vaccines10010033
Received: 2 November 2021 / Revised: 1 December 2021 / Accepted: 3 December 2021 / Published: 28 December 2021
(This article belongs to the Special Issue Frontiers in Shigella Vaccine Development)
No licensed Shigella vaccine is presently available globally. A double-blinded, randomized, placebo-controlled, age descending phase II clinical trial of a bivalent conjugate vaccine was studied in China. The vaccine ZF0901 consisted of O-specific polysaccharides purified and detoxified from lipopolysaccharide (LPS) of S. flexneri 2a and S. sonnei and covalently bonded to tetanus toxoid. A total of 224, 310, and 434 children, consented by parents or guardians, aged 3 to 6 and 6 to 12 months and 1 to 5 years old, respectively, were injected with half or full doses, with or without adjuvant or control Hib vaccine. There were no serious adverse reactions in all recipients of ZF0901 vaccine independent of age, dosage, number of injections, or the adjuvant status. Thirty days after the last injection, ZF0901 induced robust immune responses with significantly higher levels of type-specific serum antibodies (geometric mean concentrations (GMCs) of IgG anti-LPS) against both serotypes in all age groups compared with the pre-immune or the Hib control (p < 0.0001). Here, we demonstrated that ZF0901 bivalent Shigella conjugate vaccine is safe and immunogenic in infants and young children and is likely suitable for routine immunization. View Full-Text
Keywords: Shigella conjugate vaccine; bivalent; safety and immunogenicity; clinical trial; infants and young children Shigella conjugate vaccine; bivalent; safety and immunogenicity; clinical trial; infants and young children
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MDPI and ACS Style

Mo, Y.; Fang, W.; Li, H.; Chen, J.; Hu, X.; Wang, B.; Feng, Z.; Shi, H.; He, Y.; Huang, D.; Mo, Z.; Ye, Q.; Du, L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines 2022, 10, 33. https://doi.org/10.3390/vaccines10010033

AMA Style

Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines. 2022; 10(1):33. https://doi.org/10.3390/vaccines10010033

Chicago/Turabian Style

Mo, Yi, Wenjian Fang, Hong Li, Junji Chen, Xiaohua Hu, Bin Wang, Zhengli Feng, Honghua Shi, Ying He, Dong Huang, Zhaojun Mo, Qiang Ye, and Lin Du. 2022. "Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China" Vaccines 10, no. 1: 33. https://doi.org/10.3390/vaccines10010033

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