Objective To establish an efficient,sensitive,and accurate ion chromatography method for the simultaneous determination of three impurity ions—bromide(Br-),nitrite(NO2-),and oxalate(C2 O42-)—in oral rehydration salts powder(Ⅲ).These impurity ions may pose potential toxic side effects on children's health;therefore,ensuring their content within safe limits is crucial for safeguarding pediatric medication safety.Methods A Metrosep A Supp 5 column(250 mm×4.0 mm,5 μm),packed with quaternary ammonium-bonded polyvinyl alcohol was used.The eluent consisted of carbonate buffer:Mobile phase A was a mixture of 3.2 mmol·L-1 sodium carbonate and 1.0 mmol·L-1 sodium bicarbonate(50∶50,V∶V),and mobile phase B was a mixture of 32 mmol·L-1 sodium carbonate and 10 mmol·L-1 sodium bicarbonate(50∶50,V∶V),with gradient elution.The column temperature was set at 35℃,and the flow rate was 0.7 mL·min-1.Limits for the three impurity ions were set according to the International Council for Harmonisation guidelines(ICH M7(R1)and ICH Q3B),and the method was validated by testing six actual samples.Results Within the concentration range of 0.02-0.50 μg·mL-1,the linear correlation coefficients(R2)for the three impurity ions were all greater than 0.999.The detection limits ranged from 1.2 to 3.4 ng·mL-1,and the spiked recovery rates were between 92.0%and 102.0%.Results from the six actual samples demonstrated that the method effectively controlled the content of impurity ions.Conclusion This study successfully established a gradient elution ion chromatography method for the simultaneous determination of three impurity ions in Oral rehydration salts powder(Ⅲ).The method is highly sensitive,specific,and accurate.

The master protocol design encompasses a comprehensive clinical trial protocol containing multiple sub-protocols, which can be used to evaluate the clinical intervention effects of various drugs or vaccines on various diseases. Particularly, this design strategy represents an efficient and innovative approach to trial design in the context of precision medicine. The master protocol design can be used for emerging infectious diseases and urgent vaccine development in complex situations. This review aims to outline the types and concepts of master protocol design, analyze the key points and details, and discuss its application scenarios in vaccine clinical evaluations. Additionally, it will explore potential challenges that may arise during implementation to provide references for optimizing emergency clinical trial designs of infectious disease vaccines in China.

Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.

The impact of vaccines on public health and their effectiveness in controlling infectious diseases partly depends on their coverage rate, which refers to the proportion of individuals vaccinated within a specific population. Vaccination coverage is foundational data for vaccine immunization programs, a key parameter for evaluating and monitoring the implementation of vaccination plans, and an important data point in real-world post-market studies of vaccines. Additionally, research on vaccination coverage is becoming increasingly prevalent in vaccine evaluation, primarily used to establish the risk of disease incidence in populations with different vaccination coverage rates in order to assess the protective effectiveness of vaccines. This paper reviews the research methods used to assess vaccine coverage both domestically and internationally, as well as their applications in evaluating vaccine effectiveness. It also analyzes and compares the advantages and disadvantages of different research methods for measuring vaccination coverage and discusses the significance of monitoring and improving vaccine coverage rates. The goal is to promote research and application of vaccination coverage rates in China, providing a scientific basis for post-market vaccine studies and for local administrative departments to formulate immunization policies.

Objective To establish an efficient,sensitive,and accurate ion chromatography method for the simultaneous determination of three impurity ions—bromide(Br-),nitrite(NO2-),and oxalate(C2 O42-)—in oral rehydration salts powder(Ⅲ).These impurity ions may pose potential toxic side effects on children's health;therefore,ensuring their content within safe limits is crucial for safeguarding pediatric medication safety.Methods A Metrosep A Supp 5 column(250 mm×4.0 mm,5 μm),packed with quaternary ammonium-bonded polyvinyl alcohol was used.The eluent consisted of carbonate buffer:Mobile phase A was a mixture of 3.2 mmol·L-1 sodium carbonate and 1.0 mmol·L-1 sodium bicarbonate(50∶50,V∶V),and mobile phase B was a mixture of 32 mmol·L-1 sodium carbonate and 10 mmol·L-1 sodium bicarbonate(50∶50,V∶V),with gradient elution.The column temperature was set at 35℃,and the flow rate was 0.7 mL·min-1.Limits for the three impurity ions were set according to the International Council for Harmonisation guidelines(ICH M7(R1)and ICH Q3B),and the method was validated by testing six actual samples.Results Within the concentration range of 0.02-0.50 μg·mL-1,the linear correlation coefficients(R2)for the three impurity ions were all greater than 0.999.The detection limits ranged from 1.2 to 3.4 ng·mL-1,and the spiked recovery rates were between 92.0%and 102.0%.Results from the six actual samples demonstrated that the method effectively controlled the content of impurity ions.Conclusion This study successfully established a gradient elution ion chromatography method for the simultaneous determination of three impurity ions in Oral rehydration salts powder(Ⅲ).The method is highly sensitive,specific,and accurate.

Maternal immunization is a highly effective public health strategy. The administration of vaccines to pregnant women increases the level of specific transplacental maternal antibodies, thereby protecting the pregnant fetuses, newborns, and early-life infants from the corresponding pathogens. Currently, maternal immunization strategies for pertussis, influenza, etc. have been widely used worldwide, and positive results have been achieved in preventing respiratory syncytial virus infection in infants. This article reviews different designs of maternal vaccination clinical studies, including randomized controlled trials, cohort studies, case-control studies, and surveillance data studies. It summarizes the strengths and weaknesses of different study approaches and discusses the application of maternal immunization strategies to provide a reference for developing maternal immunization research in China.

The master protocol design encompasses a comprehensive clinical trial protocol containing multiple sub-protocols, which can be used to evaluate the clinical intervention effects of various drugs or vaccines on various diseases. Particularly, this design strategy represents an efficient and innovative approach to trial design in the context of precision medicine. The master protocol design can be used for emerging infectious diseases and urgent vaccine development in complex situations. This review aims to outline the types and concepts of master protocol design, analyze the key points and details, and discuss its application scenarios in vaccine clinical evaluations. Additionally, it will explore potential challenges that may arise during implementation to provide references for optimizing emergency clinical trial designs of infectious disease vaccines in China.

Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.

The impact of vaccines on public health and their effectiveness in controlling infectious diseases partly depends on their coverage rate, which refers to the proportion of individuals vaccinated within a specific population. Vaccination coverage is foundational data for vaccine immunization programs, a key parameter for evaluating and monitoring the implementation of vaccination plans, and an important data point in real-world post-market studies of vaccines. Additionally, research on vaccination coverage is becoming increasingly prevalent in vaccine evaluation, primarily used to establish the risk of disease incidence in populations with different vaccination coverage rates in order to assess the protective effectiveness of vaccines. This paper reviews the research methods used to assess vaccine coverage both domestically and internationally, as well as their applications in evaluating vaccine effectiveness. It also analyzes and compares the advantages and disadvantages of different research methods for measuring vaccination coverage and discusses the significance of monitoring and improving vaccine coverage rates. The goal is to promote research and application of vaccination coverage rates in China, providing a scientific basis for post-market vaccine studies and for local administrative departments to formulate immunization policies.

Central memory T (Tcm) cells are a crucial subset in T cell development, playing an important role in long-term immune responses. Tcm cells exhibit strong proliferative capacity, long-term survival characteristics, and re-activation potential, enabling them to rapidly differentiate into effector T cells (Teff) upon antigen re-exposure, thus providing robust immune protection. The function of Tcm cells is regulated by various factors, including antigen exposure, cytokines, and metabolic conditions. A deeper understanding of their metabolic and epigenetic mechanisms under different pathological conditions will contribute to the development of more precise and effective immunotherapeutic strategies. This review elaborates on the origin and characteristics of Tcm cells, as well as their roles in antiviral responses, tumor immunity, and immunotherapy.
Humans ; Memory T Cells/cytology* ; Animals ; Immunologic Memory ; Neoplasms/therapy* ; Immunotherapy