BACKGROUNDAlthough China's Expanded Program on Immunization (EPI) provides two doses of group A meningococcal polysaccharide vaccine (MPV-A) for children younger than 2 y, more self-paying group A and group C meningococcal polysaccharide conjugate vaccine (MCV-AC) has been used as an alternative to MPV-A, to prevent Neisseria meningitidis serogroup C (Men-C) earlier. We evaluated the pattern of MPV-A and MCV-AC utilization to provide evidence for China to upgrade the national meningococcal meningitis vaccination strategy.METHODSChildren born between 2008 and 2017 registered in Hangzhou's Immunization Information System (HZIIS) were included. Descriptive epidemiological methods were used to characterize the data. Adverse event following immunization (AEFI) was collected from Chinese national adverse event following immunization information system (CNAEFIIS) to compare the safety of MPV-A and MCV-AC.RESULTSData of 1149,027 children from HZIIS were analyzed. The average immunization rate of meningococcal meningitis vaccine (MenV) was 97.50%. Percentages of children using MPV-A-only, MCV-AC-only, and MPV-A/MCV-AC sequential schedules were 68.20%, 29.73%, and 2.07%, respectively. The vaccination rate of MCV-AC-only increased by age and it was higher in resident children than migration children. The incidence rate of AEFI of MPV-A and MCV-AC was 53.36 per 100,000 and 62.13 per 100,000, respectively.CONCLUSIONChildren in Hangzhou had high MenV coverage. MCV-AC-only schedule use increased by year and was higher in urban areas among locally born children. Both MPV-A and MCV-AC were safe for children, while MCV-AC could protect against Men-C more effectively. This supports the rationale to introduce MCV-AC into China's EPI system for free instead of MPV-A.

06 Sep 2020·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants].

Article

Author: Zhu, T ; Huang, H T ; Huang, L L ; Xie, Z Q ; Wang, Y X ; Xia, S L ; Zhao, D Y ; Xu, L F ; Gou, J B ; Wang, X ; Zhang, W ; Yang, Y L

Objective: The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. Methods: From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). Results: The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (P<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (P<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (P<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (P<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (P>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (P>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (P<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (P<0.001). Conclusion: ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.

01 Jan 2020·Japanese Journal of Infectious Diseases

A Novel Reporter Gene Assay for Pyrogen Detection

Article

Author: Wang, Lan ; Du, Ying ; Ni, Yongbo ; He, Qing ; Zhang, Heng ; Wang, Junzhi ; Yu, Chuanfei ; Gao, Hua

Fever is a systemic inflammatory response of the body to pyrogens. Nuclear factor κB (NF-κB) is a central signaling molecule that causes the excessive secretion of various pyrogen-induced pro-inflammatory factors. This study explored the feasibility of a novel reporter gene assay (RGA) for pyrogen detection using RAW264.7 cells stably transfected with the NF-κB reporter gene as a pyrogenic marker. The RGA could detect different types of pyrogens, including the lipopolysaccharide of gram-negative bacteria, the lipoteichoic acid of gram-positive bacteria, and the zymosan of fungi, and a good dose-effect relationship was observed in terms of NF-κB activity. The limits of detection of the RGA to those pyrogens were 0.03 EU/ml, 0.001 μg/ml, and 1 μg/ml, respectively. The method had good precision and accuracy and could be applied to many molecules (e.g., nivolumab, rituximab, bevacizumab, etanercept, basiliximab, Haemophilus influenzae type b conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, group A and group C meningococcal conjugate vaccine, diphtheria, tetanus, pertussis [acellular, component], poliomyelitis [inactivated] vaccine, and imject alum adjuvant). The results of this study suggest that the novel RGA has a wide pyrogen detection spectrum and is sufficiently sensitive, stable, and accurate for various applications.

100 Deals associated with Meningococcal Group A, C Bivalent Polysaccharide Conjugate Vaccine(Walvax Biotechnology Co., Ltd.)

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Indication	Country/Location	Organization	Date
Meningitis, Meningococcal	CN	Yuxi Walvax Biotechnology Co., Ltd.	04 Jan 2009

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