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Zong X.-K.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Zhu W.-H.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Zhao Y.-Y.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Du L.,Beijing Zhifei Lvzhu Biopharmaceutical Co.
Chinese Journal of Biologicals | Year: 2015

Objective: To investigate the application of nuclear magnetic resonance (NMR) spectrum in preparation of bivalent Shigella conjugate vaccine. Methods: Using Agilent 600 MHz NMR spectrometer, the repeating structural units of S. flexneri 2a polysaccharide and S. sonnei polysaccharide were analyzed by 1H NMR and 13C NMR, while those of polysaccharides, derivatives and conjugates in production procedure were analyzed by 'H NMR. Results: The 'H NMR and 13C NMR data and spectrums of Shigella polysaccharides were highly consistent with those in documents. The analysis of polysaccharides in production procedure by 1H NMR proved the reaction mechanism of the procedure. Conclusion: In the development of bivalent Shigella conjugate vaccine, NMR spectrum may be used for the direct determination of chemical structure of polysaccharide as well as the quality control of structure and modification level of polysaccharide as a raw material during derivation. Source


Zheng J.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Zhu X.-G.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Liu G.,Beijing Zhifei Lvzhu Biopharmaceutical Co. | Du L.,Beijing Zhifei Lvzhu Biopharmaceutical Co.
Chinese Journal of Biologicals | Year: 2015

Objective To observe the immunogenicity and immune persistence of groups A&C meningococcal polysaccharide conjugate vaccine in infants at various ages. Methods A total of 1 190 infants in Long'an County, Nanning City, Guangxi Zhuang Autonomous Region, China were divided into three age groups, i. e. 3 ∼ 8 months (220 in trial and 133 in control groups), 1 ∼ 2 years (202 in trial and 212 in control groups) and 3 ∼ 4 years (218 in trial and 205 in control groups). The infants in trial groups were injected i. m. with groups A&C meningococcal polysaccharide conjugate vaccine, while those in control groups with groups A&C meningococcal polysaccharide vaccine. The infants at ages of 3 ∼ 8 months were immunized for 3 times, while those at ages of 1 ∼ 2 years for 2 times, each at an interval of one month, and those at ages of 3 ∼ 4 years with a single dose. The dosage of vaccine was 0.5 ml. Serum samples were collected before immunization, 4 weeks after the second dose, 4 weeks after the third dose and 3 years after the last dose in the infants at ages of 3 ∼ 8 months, before immunization, 4 weeks after the second dose and 3 years after the last dose in those at ages of 1 ∼ 2 years, and before and 4 weeks and 3 years after immunization in those at ages of 3 ∼ 4 years, determined for antibody level by bactericidal test and ELISA, and observed for immune effect and change of antibody level as time went on. Results The antibody levels of infants at various ages increased significantly after immunization with groups A&C meningococcal polysaccharide conjugate vaccine, and were persistent 3 years after immunization. Conclusion Groups A&C meningococcal polysaccharide conjugate vaccine induced and maintained antibodies at immune protection levels in infants at various ages. Source

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