1.Clinical research design and application of vaccines based on maternal immunization
Yue LIU ; Siyue JIA ; Xinmo MA ; Feng WEN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(2):345-351
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.
2.Research methods of vaccination coverage and their application in evaluating vaccine protective effectiveness
Weiwei HAN ; Siyue JIA ; Hongyan LIU ; Yue LIU ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(9):1673-1679
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.
3.Clinical research design and application of vaccines based on maternal immunization
Yue LIU ; Siyue JIA ; Xinmo MA ; Feng WEN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(2):345-351
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.
4.Research methods of vaccination coverage and their application in evaluating vaccine protective effectiveness
Weiwei HAN ; Siyue JIA ; Hongyan LIU ; Yue LIU ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(9):1673-1679
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.
5.Impact of hyperuricemia on the clinical outcomes in patients with polycystic ovary syndrome undergoing in vitro fertilization and embryo transfer
Ting ZHANG ; Haoying HAO ; Siyue XU ; Nan JIA ; Lifeng TIAN ; Shaodi ZHANG
Chinese Journal of Reproduction and Contraception 2024;44(12):1235-1241
Objective:To investigate the impact of hyperuricemia on the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle in patients with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization and embryo transfer (IVF-ET). Methods:A retrospective cohort study was conducted on data from 3 959 PCOS patients who received IVF-ET treatment at the Reproductive Centers of Henan Provincial People's Hospital and Jiangxi Provincial Maternal and Child Health Hospital between January 2016 and December 2021. The patients were divided into hyperuricemia group (>357 μmol/L, n=1 126) and normal uric acid group (≤357 μmol/L, n=2 833) based on their uric acid levels. Baseline data, clinical and laboratory indicators were compared between the two groups. Univariate and multivariate regression analyses were performed on factors influencing clinical outcomes. Multivariate logistic regression analysis was used to compare the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle between the two groups, clarifying the impact of hyperuricemia on clinical outcomes in PCOS patients. Results:There were no significant differences between the two groups in terms of age, duration of infertility, baseline testosterone level, type of infertility, and the rate of unusable embryos (all P>0.05). Body mass index [BMI, (25.15±3.75) kg/m 2], fasting blood glucose [(4.99±0.80) mmol/L] and fasting insulin levels [17.19 (11.78, 25.30) mU/L] in hyperuricemia group were higher than those in normal uric acid group [(23.60±3.64) kg/m 2, P<0.001; (4.88±0.81) mmol/L, P<0.001;12.40 (8.59, 17.86) mU/L, P<0.001], while their baseline luteinizing hormone [7.62 (4.68, 11.18) U/L] and anti-Müllerian hormone [7.62 (5.34, 10.73) μg/L] levels were lower than those in normal uric acid group [7.88 (4.98, 11.91) U/L, P=0.024; 7.95 (5.49, 11.73) μg/L, P<0.001], with statistically significant differences. Multivariate logistic regression analysis indicated that female BMI, endometrial thickness on human chorionic gonadotropin (hCG) injection day, and the number of transferable embryos were factors influencing the live birth rate per transfer cycle ( OR=1.02, 95% CI: 1.00-1.04, P=0.044; OR=0.95, 95% CI: 0.92-0.97, P<0.001; OR=0.97, 95% CI: 0.95-0.99, P=0.006). Fasting blood glucose, endometrial thickness on hCG injection day, and the number of transferable embryos were factors influencing the cumulative live birth rate per oocyte retrieval cycle ( OR=1.14, 95% CI: 1.01-1.29, P=0.036; OR=0.92, 95% CI: 0.87-0.97, P=0.002; OR=0.70, 95% CI: 0.66-0.75, P<0.001). Compared with the normal uric acid group, the hyperuricemia group in PCOS patients had not a statistically signifcant decrease in the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle ( OR=0.93, 95% CI: 0.72-1.19, P=0.548; OR=1.18, 95% CI: 0.87-1.60, P=0.300). Conclusion:Hyperuricemia does not affect the live birth rate per transfer cycle or the cumulative live birth rate per oocyte retrieval cycle in PCOS patients undergoing IVF-ET.
6.Impact of hyperuricemia on the clinical outcomes in patients with polycystic ovary syndrome undergoing in vitro fertilization and embryo transfer
Ting ZHANG ; Haoying HAO ; Siyue XU ; Nan JIA ; Lifeng TIAN ; Shaodi ZHANG
Chinese Journal of Reproduction and Contraception 2024;44(12):1235-1241
Objective:To investigate the impact of hyperuricemia on the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle in patients with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization and embryo transfer (IVF-ET). Methods:A retrospective cohort study was conducted on data from 3 959 PCOS patients who received IVF-ET treatment at the Reproductive Centers of Henan Provincial People's Hospital and Jiangxi Provincial Maternal and Child Health Hospital between January 2016 and December 2021. The patients were divided into hyperuricemia group (>357 μmol/L, n=1 126) and normal uric acid group (≤357 μmol/L, n=2 833) based on their uric acid levels. Baseline data, clinical and laboratory indicators were compared between the two groups. Univariate and multivariate regression analyses were performed on factors influencing clinical outcomes. Multivariate logistic regression analysis was used to compare the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle between the two groups, clarifying the impact of hyperuricemia on clinical outcomes in PCOS patients. Results:There were no significant differences between the two groups in terms of age, duration of infertility, baseline testosterone level, type of infertility, and the rate of unusable embryos (all P>0.05). Body mass index [BMI, (25.15±3.75) kg/m 2], fasting blood glucose [(4.99±0.80) mmol/L] and fasting insulin levels [17.19 (11.78, 25.30) mU/L] in hyperuricemia group were higher than those in normal uric acid group [(23.60±3.64) kg/m 2, P<0.001; (4.88±0.81) mmol/L, P<0.001;12.40 (8.59, 17.86) mU/L, P<0.001], while their baseline luteinizing hormone [7.62 (4.68, 11.18) U/L] and anti-Müllerian hormone [7.62 (5.34, 10.73) μg/L] levels were lower than those in normal uric acid group [7.88 (4.98, 11.91) U/L, P=0.024; 7.95 (5.49, 11.73) μg/L, P<0.001], with statistically significant differences. Multivariate logistic regression analysis indicated that female BMI, endometrial thickness on human chorionic gonadotropin (hCG) injection day, and the number of transferable embryos were factors influencing the live birth rate per transfer cycle ( OR=1.02, 95% CI: 1.00-1.04, P=0.044; OR=0.95, 95% CI: 0.92-0.97, P<0.001; OR=0.97, 95% CI: 0.95-0.99, P=0.006). Fasting blood glucose, endometrial thickness on hCG injection day, and the number of transferable embryos were factors influencing the cumulative live birth rate per oocyte retrieval cycle ( OR=1.14, 95% CI: 1.01-1.29, P=0.036; OR=0.92, 95% CI: 0.87-0.97, P=0.002; OR=0.70, 95% CI: 0.66-0.75, P<0.001). Compared with the normal uric acid group, the hyperuricemia group in PCOS patients had not a statistically signifcant decrease in the live birth rate per transfer cycle and the cumulative live birth rate per oocyte retrieval cycle ( OR=0.93, 95% CI: 0.72-1.19, P=0.548; OR=1.18, 95% CI: 0.87-1.60, P=0.300). Conclusion:Hyperuricemia does not affect the live birth rate per transfer cycle or the cumulative live birth rate per oocyte retrieval cycle in PCOS patients undergoing IVF-ET.
7.Exploration and application of a novel attempt to recruit participants in clinical trials of vaccines under the emergency
Hudachuan JIANG ; Zhao WANG ; Lei WANG ; Wenjuan WANG ; Hu WANG ; Peng DENG ; Siyue JIA ; Zhaohua LIU ; Fengcai ZHU
Chinese Journal of Preventive Medicine 2020;54(9):963-967
Objective:To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations.Methods:To publish recruitment notice in local areas of Wuhan through websites and medium, and guide interested persons to log in to the“Clinical Trials of SARS-CoV-2 Vaccine Reservation and Health Declaration System”to appoint and register their health information. The "Health Declaration System" provides each volunteer evaluation and risk levels to preliminarily exclude those who do not meet the inclusion criteria. Researchers review the qualified volunteers by telephone, organize them to go to the vaccination site, and finally conduct a strict medical screening to determine the final subjects.Results:A total of 4 819 people and 5 132 people registered in the Phase Ⅰ and Phase Ⅱ recruitment system respectively, with men 2 912 (60.43%) and 2 887 (56.25%) more than women 1 907 (39.57%) and 2 245 (43.75%), mostly in the 20-39 age group, with 3 211 (66.63%) and 3 966 (77.28%). All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the Phase Ⅱ recruitment system was higher than that of Phase Ⅰ, with men 2 047 (70.28%) and 2 135(73.95%), higher than women 1 083 (56.80%) and 1 472 (65.57%); 440 and 689 people were reviewed by telephone in Phase Ⅰ and Phase Ⅱ respectively, and the number of verified volunteers was about 440 (35.00%) and 689 (67.20%); Of the 201 603 people who arrived at the vaccination site, 12 and 26 of them were positive for the SARS-CoV-2 antibody with an antibody positive rate of 6.00% and 4.31% respectively.Conclusion:The novel method for recruiting subjects in this clinical study is efficient and reliable, and the recruitment situation of Phase Ⅰ had set a good example for Phase Ⅱ but the medium-and long-term compliance of subjects and the separation of willingness and behaviors still need to be further studied.
8.Exploration and application of a novel attempt to recruit participants in clinical trials of vaccines under the emergency
Hudachuan JIANG ; Zhao WANG ; Lei WANG ; Wenjuan WANG ; Hu WANG ; Peng DENG ; Siyue JIA ; Zhaohua LIU ; Fengcai ZHU
Chinese Journal of Preventive Medicine 2020;54(9):963-967
Objective:To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations.Methods:To publish recruitment notice in local areas of Wuhan through websites and medium, and guide interested persons to log in to the“Clinical Trials of SARS-CoV-2 Vaccine Reservation and Health Declaration System”to appoint and register their health information. The "Health Declaration System" provides each volunteer evaluation and risk levels to preliminarily exclude those who do not meet the inclusion criteria. Researchers review the qualified volunteers by telephone, organize them to go to the vaccination site, and finally conduct a strict medical screening to determine the final subjects.Results:A total of 4 819 people and 5 132 people registered in the Phase Ⅰ and Phase Ⅱ recruitment system respectively, with men 2 912 (60.43%) and 2 887 (56.25%) more than women 1 907 (39.57%) and 2 245 (43.75%), mostly in the 20-39 age group, with 3 211 (66.63%) and 3 966 (77.28%). All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the Phase Ⅱ recruitment system was higher than that of Phase Ⅰ, with men 2 047 (70.28%) and 2 135(73.95%), higher than women 1 083 (56.80%) and 1 472 (65.57%); 440 and 689 people were reviewed by telephone in Phase Ⅰ and Phase Ⅱ respectively, and the number of verified volunteers was about 440 (35.00%) and 689 (67.20%); Of the 201 603 people who arrived at the vaccination site, 12 and 26 of them were positive for the SARS-CoV-2 antibody with an antibody positive rate of 6.00% and 4.31% respectively.Conclusion:The novel method for recruiting subjects in this clinical study is efficient and reliable, and the recruitment situation of Phase Ⅰ had set a good example for Phase Ⅱ but the medium-and long-term compliance of subjects and the separation of willingness and behaviors still need to be further studied.
9.Correlation between intestinal microbiota and immune response to vaccination
Siyue JIA ; Jingxin LI ; Fengcai ZHU
Chinese Journal of Microbiology and Immunology 2018;38(3):237-240
Intestinal microbiota plays an important role in the development of immune system,es-pecially in the formation of immune response. Immune response to vaccination varies with region and popula-tion,which may be related to the differences in intestinal microbiota. This review focused on the correlation between intestinal microbiota and immune response to vaccination in order to find a new way to enhance vac-cine-induced immune response. It was revealed that intestinal microbiota might be involved in the immune responses to vaccines against rotavirus, typhoid and polio. Although probiotics, prebiotics and synbiotics could not significantly enhance vaccine-induced immune response,they might have a beneficial effect on vac-cine by regulating intestinal microbiota.
10.Effects of Paclitaxel Combined with Cisplatin on the Proliferation,Migration and Invasion of Thyroid Can-cer Cells SW579
Jiuyi YANG ; Siyue JIA ; Lingqiao WU ; Caifen ZHANG ; Jianping GONG ; Dandan KONG
China Pharmacy 2015;(34):4782-4785
OBJECTIVE:To study the effects of paclitaxel combined with cisplatin on the proliferation,migration and invasion of thyroid cancer cells SW579 and its mechanism. METHODS:Cells were divided into blank control group,paclitaxel group (3μmol/L),cisplatin group(30 μmol/L),drug combination group(paclitaxel 3 μmol/L+cisplatin 30 μmol/L). 48 h after culture,the relative cell activity was measured by MTT assay. Cell cycle was detected by flow cytometry. Migration and invasion of cell was tested by Transwell assay. The expression of phosphatase and tensin homolog deleted on chromosome ten(PTEN),protein kinase B(AKT),Cyclin D1,p27,matrix metalloproteinase(MMP)-2 and MMP-9 were detected by Western blot. RESULTS:Compared with blank control group,relative cell activity of all treatment groups were decreased;paclitaxel or plus cisplatin also made cell cy-cle arrest in G1 phase,and migration and invasion ability of cell were decreased;the expression of PTEN and p27 remarkably in-creased,while the expression of Cyclin D1,MMP-2,MMP-9 and phosphorylation of AKT were obviously reduced,with statisti-cal significance (P<0.05). Compared with single drug group,the effect of drug combination group strengthened,with statistical significance in above indicators(P<0.05). CONCLUSIONS:The inhibition effect of paclitaxel combined with cisplatin on the pro-liferation,migration and invasion of thyroid cancer cells SW579 cell will be strengthened,by a mechanism of up-regulating the ex-pression of PTEN and p27,down-regulating the expression of Cyclin D1,MMP-2 and MMP-9,inhibiting phosphorylation of AKT.

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