1.Immunogenicity and immune persistence of human rabies vaccine (Vero cell) in healthy people aged 10-17 years
Zhenzhen LIANG ; Yugang SHEN ; Xiaosong HU ; Bo XING ; Xinpei ZHANG ; Yingping CHEN ; Yu MAO ; Huakun LYU
Chinese Journal of Microbiology and Immunology 2025;45(2):135-140
Objective:To evaluate the immunogenicity and immune persistence of human rabies vaccine (Vero cell) in healthy people aged 10-17 years and compare it with a group of adults aged 18-60 years.Methods:This study was conducted between July 2021 and November 2022 with Shangyu district and Shengzhou city of Shaoxing city, Zhejiang Province selected as the research sites. Zagreb regimen (2-1-1 schedule) and Essen regimen (1-1-1-1-1 schedule) were used for rabies vaccine administration. Serum samples were collected at different time points before and after immunization to compare the differences in seropositivity rates and geometric mean concentrations (GMC) between the 10-17 age group and the 18-60 age group.Results:A total of 1 200 healthy participants aged 10-60 were included, with 157 individuals (13.1%) in the 10-17 age group and 1 043 individuals (86.9%) in the 18-60 age group. Both groups displayed a nearly 100% seropositivity rate at 3, 6 and 12 months, and the participants in the same age group had similar antibody levels. The GMC of antibodies gradually increased after vaccination and peaked on 14 d. The 10-17 age group showed higher GMC of antibodies than the 18-60 age group at 14 d after the first dose (Zagreb regimen: 81.85 IU/ml vs 63.15 IU/ml, t=2.411, P=0.018; Essen regimen: 86.61 IU/ml vs 69.24 IU/ml, t=3.906, P<0.001). Similar differences were observed in the GMC of antibodies at 14 d and 3 months after the full vaccination course, but these differences gradually decreased and disappeared at 6 and 12 months after vaccination. Conclusions:Human rabies vaccine (Vero cell) has lasting immune protection in all participants within one year after vaccination, with no significant differences between the two vaccination regimens. Participants aged 10-17 have higher antibody levels compared to adults aged 18-60, but there is no significant difference in immune persistence between the two age groups.
2.Development and reliability and validity testing of the questionnaire on rotavirus vaccination behavioral and social drivers
Yuting LIAO ; Xiaodong SUN ; Zhuoying HUANG ; Huakun LYU ; Zhiguo WANG ; Binbing WANG ; Jiaxi DU ; Yaqiong LIANG ; Jiangshun WAN ; Zhi LI ; Jing QIU ; Fang HUANG ; Juan LI ; Xiang GUO
Chinese Journal of Preventive Medicine 2025;59(11):1883-1888
Objective:To construct a questionnaire to measure parents′ behavioral and social drivers (BeSD) in administering rotavirus vaccine to their children, and to test the reliability and validity of the questionnaire.Methods:A questionnaire was constructed to investigate the BeSD of rotavirus vaccination among parents based on the WHO BeSD questionnaire. A survey was conducted among parents of children aged 0-3 years old in vaccination clinics from 15 community health service centers in Nanjing City of Jiangsu Province, Yuhuan and Kaihua Counties of Zhejiang Province, Anqing City of Anhui Province, and Yangpu District of Shanghai City from April to May in 2024. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to analyze the reliability (internal consistency reliability, combination reliability and split half reliability) and validity (structural validity, convergence validity and discriminative validity) of the questionnaire.Results:A total of 850 questionnaires were collected, of which 614 were valid, with an effective response rate of 72.20%. The EFA resulted in the refinement of the rotavirus vaccine BeSD questionnaire from 37 to 35 items (including 24 core items), and suggested a five-factor structure including the perceptions of vaccine, confidence in vaccine, social process of vaccination, motivation for vaccination, and practical problems of vaccination. The cumulative variance contribution rate reached 56.27%. The CFA confirmed an ideal five-factor model fit (GFI=0.82,CFI=0.86,PNFI=0.67,RMSEA=0.07). The AVE of each dimension was greater than 0.50. The AVE square root of each dimension of the questionnaire was greater than its correlation coefficient. The Cronbach′s α coefficient of the total questionnaire was 0.79.Conclusion:The developed BeSD questionnaire of rotavirus vaccine has good reliability and validity, and can be used to measure parents′ behavioral and social factors in administering rotavirus vaccine to their children.
3.Immunogenicity and immune persistence of human rabies vaccine (Vero cell) in healthy people aged 10-17 years
Zhenzhen LIANG ; Yugang SHEN ; Xiaosong HU ; Bo XING ; Xinpei ZHANG ; Yingping CHEN ; Yu MAO ; Huakun LYU
Chinese Journal of Microbiology and Immunology 2025;45(2):135-140
Objective:To evaluate the immunogenicity and immune persistence of human rabies vaccine (Vero cell) in healthy people aged 10-17 years and compare it with a group of adults aged 18-60 years.Methods:This study was conducted between July 2021 and November 2022 with Shangyu district and Shengzhou city of Shaoxing city, Zhejiang Province selected as the research sites. Zagreb regimen (2-1-1 schedule) and Essen regimen (1-1-1-1-1 schedule) were used for rabies vaccine administration. Serum samples were collected at different time points before and after immunization to compare the differences in seropositivity rates and geometric mean concentrations (GMC) between the 10-17 age group and the 18-60 age group.Results:A total of 1 200 healthy participants aged 10-60 were included, with 157 individuals (13.1%) in the 10-17 age group and 1 043 individuals (86.9%) in the 18-60 age group. Both groups displayed a nearly 100% seropositivity rate at 3, 6 and 12 months, and the participants in the same age group had similar antibody levels. The GMC of antibodies gradually increased after vaccination and peaked on 14 d. The 10-17 age group showed higher GMC of antibodies than the 18-60 age group at 14 d after the first dose (Zagreb regimen: 81.85 IU/ml vs 63.15 IU/ml, t=2.411, P=0.018; Essen regimen: 86.61 IU/ml vs 69.24 IU/ml, t=3.906, P<0.001). Similar differences were observed in the GMC of antibodies at 14 d and 3 months after the full vaccination course, but these differences gradually decreased and disappeared at 6 and 12 months after vaccination. Conclusions:Human rabies vaccine (Vero cell) has lasting immune protection in all participants within one year after vaccination, with no significant differences between the two vaccination regimens. Participants aged 10-17 have higher antibody levels compared to adults aged 18-60, but there is no significant difference in immune persistence between the two age groups.
4.Development and reliability and validity testing of the questionnaire on rotavirus vaccination behavioral and social drivers
Yuting LIAO ; Xiaodong SUN ; Zhuoying HUANG ; Huakun LYU ; Zhiguo WANG ; Binbing WANG ; Jiaxi DU ; Yaqiong LIANG ; Jiangshun WAN ; Zhi LI ; Jing QIU ; Fang HUANG ; Juan LI ; Xiang GUO
Chinese Journal of Preventive Medicine 2025;59(11):1883-1888
Objective:To construct a questionnaire to measure parents′ behavioral and social drivers (BeSD) in administering rotavirus vaccine to their children, and to test the reliability and validity of the questionnaire.Methods:A questionnaire was constructed to investigate the BeSD of rotavirus vaccination among parents based on the WHO BeSD questionnaire. A survey was conducted among parents of children aged 0-3 years old in vaccination clinics from 15 community health service centers in Nanjing City of Jiangsu Province, Yuhuan and Kaihua Counties of Zhejiang Province, Anqing City of Anhui Province, and Yangpu District of Shanghai City from April to May in 2024. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to analyze the reliability (internal consistency reliability, combination reliability and split half reliability) and validity (structural validity, convergence validity and discriminative validity) of the questionnaire.Results:A total of 850 questionnaires were collected, of which 614 were valid, with an effective response rate of 72.20%. The EFA resulted in the refinement of the rotavirus vaccine BeSD questionnaire from 37 to 35 items (including 24 core items), and suggested a five-factor structure including the perceptions of vaccine, confidence in vaccine, social process of vaccination, motivation for vaccination, and practical problems of vaccination. The cumulative variance contribution rate reached 56.27%. The CFA confirmed an ideal five-factor model fit (GFI=0.82,CFI=0.86,PNFI=0.67,RMSEA=0.07). The AVE of each dimension was greater than 0.50. The AVE square root of each dimension of the questionnaire was greater than its correlation coefficient. The Cronbach′s α coefficient of the total questionnaire was 0.79.Conclusion:The developed BeSD questionnaire of rotavirus vaccine has good reliability and validity, and can be used to measure parents′ behavioral and social factors in administering rotavirus vaccine to their children.
5.Safety and effectiveness of COVID-19 vaccines among the elderly in the real world
Xu CHEN ; Lingxian QIU ; Xiaohui LIU ; Yingying SU ; Huakun LYU
Chinese Journal of Microbiology and Immunology 2024;44(7):646-652
The elderly are prone to develop severe disease or die after infection with SARS-CoV-2, and inoculation of COVID-19 vaccine is of great significance to reduce the serious case and death. Several COVID-19 vaccines have been administered and demonstrated their safety and effectiveness in the real world. This review summarizes the safety and effectiveness of COVID-19 vaccines in the real-world studies, especially the rare adverse reactions associated with vaccine and protection against severe disease, hospitalization and death in different epidemiological contexts.
6.Immunogenicity, safety and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years
Dingyan YAO ; Yingping CHEN ; Fan DING ; Xiaosong HU ; Zhenzhen LIANG ; Bo XING ; Yifei CAO ; Tianqi ZHANG ; Xilu WANG ; Yuting LIAO ; Juan YANG ; Huakun LYU
Chinese Journal of Preventive Medicine 2024;58(1):25-32
Objective:To evaluate the immunogenicity, safety, and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years.Methods:An open-label, multi-center trial was conducted in October 2021. The eligible healthy individuals, aged 18-84 years who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, were recruited from Shangyu district of Shaoxing and Kaihua county of Quzhou, Zhejiang province. All participants were divided into three groups based on the differences in prime-boost intervals: Group A (3-4 months), Group B (5-6 months) and Group C (7-9 months), with 320 persons per group. All participants received the recombinant COVID-19 vaccine (CHO cell). Blood samples were collected before the vaccination and after receiving the booster at 14 days, 30 days, and 180 days for analysis of GMTs, antibody positivity rates, and seroconversion rates. All adverse events were collected within one month and serious adverse events were collected within six months. The incidences of adverse reactions were analyzed after the booster.Results:The age of 960 participants was (52.3±11.5) years old, and 47.4% were males (455). The GMTs of Groups B and C were 65.26 (54.51-78.12) and 60.97 (50.61-73.45) at 14 days after the booster, both higher than Group A′s 44.79 (36.94-54.30) ( P value<0.05). The GMTs of Groups B and C were 23.95 (20.18-28.42) and 27.98 (23.45-33.39) at 30 days after the booster, both higher than Group A′s 15.71 (13.24-18.63) ( P value <0.05). At 14 days after the booster, the antibody positivity rates in Groups A, B, and C were 91.69% (276/301), 94.38% (302/320), and 93.95% (295/314), respectively. The seroconversion rates in the three groups were 90.37% (272/301), 93.75% (300/320), and 93.31% (293/314), respectively. There was no significant difference among these rates in the three groups (all P values >0.05). At 30 days after the booster, antibody positivity rates in Groups A, B, and C were 79.60% (238/299), 87.74% (279/318), and 90.48% (285/315), respectively. The seroconversion rates in the three groups were 76.92% (230/299), 85.85% (273/318), and 88.25% (278/315), respectively. There was a significant difference among these rates in the three groups (all P values <0.001). During the sequential booster immunization, the incidence of adverse events in 960 participants was 15.31% (147/960), with rates of about 14.38% (46/320), 17.50% (56/320), and 14.06% (45/320) in Groups A, B, and C, respectively. The incidence of adverse reactions was 8.02% (77/960), with rates of about 7.50% (24/320), 6.88% (22/320), and 9.69% (31/320) in Groups A, B, and C, respectively. No serious adverse events related to the booster were reported. Conclusion:Healthy individuals aged 18-84 years, who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, have good immunogenicity and safety profiles following the sequential booster with the recombinant COVID-19 vaccine (CHO cell).
7.The prevalence rate and influencing factors of cough in children under 5 years old in Yiwu city, Zhejiang Province in 2019
Hui LIANG ; Linling DING ; Hanqing HE ; Huakun LYU ; Zhujun SHAO ; Jianxing YU ; Jian FU
Chinese Journal of Preventive Medicine 2021;55(10):1214-1219
Objectives:To investigate the prevalence of cough and its influencing factors in community children under 5 years old.Methods:From October to December 2019, we selected 3 102 community children under the age of 5 from 50 natural villages/residential communities in 14 towns/streets of Yiwu, Zhejiang Province, using multi-stage random sampling method. A face-to-face and on-site questionnaire survey was conducted among child caregivers to collect demographic data and information about children′s cough in the last 1 month. Multiple logistic regression model was used to analyze children′s cough and the influencing factors of different cough states.Results:Multivariate logistic regression model analysis results showed that compared with 0-1 year old, dispersed, caregivers with education level below high school, families with 1 child under 5 years old, Cough risk was higher in 1-2, 2-3, 3-4 years old, nurseries, caregivers with education level of high school or above, and families with more than 2 children under 5 years old. OR (95% CI) values were 1.52(1.19-1.92), 1.65(1.29-2.10), 1.86(1.36-2.54), 2.59(1.99-3.38), 1.48(1.26-1.74) and 1.35(1.13-1.62), respectively. Further analysis of the influencing factors of different states of cough, multivariate logistic regression model analysis results showed that preschool status, the number of children under 5 years old in the family and the education level of caregivers were the influencing factors of acute, prolonged and chronic cough. Age was only an influencing factor of acute and persistent cough. Conclusions:The disease burden of cough in children under 5 years old community was heavy, and the cough was related to children′s age, education level of caregivers, number of children under 5 years old in the family and childcare status.
8.The prevalence rate and influencing factors of cough in children under 5 years old in Yiwu city, Zhejiang Province in 2019
Hui LIANG ; Linling DING ; Hanqing HE ; Huakun LYU ; Zhujun SHAO ; Jianxing YU ; Jian FU
Chinese Journal of Preventive Medicine 2021;55(10):1214-1219
Objectives:To investigate the prevalence of cough and its influencing factors in community children under 5 years old.Methods:From October to December 2019, we selected 3 102 community children under the age of 5 from 50 natural villages/residential communities in 14 towns/streets of Yiwu, Zhejiang Province, using multi-stage random sampling method. A face-to-face and on-site questionnaire survey was conducted among child caregivers to collect demographic data and information about children′s cough in the last 1 month. Multiple logistic regression model was used to analyze children′s cough and the influencing factors of different cough states.Results:Multivariate logistic regression model analysis results showed that compared with 0-1 year old, dispersed, caregivers with education level below high school, families with 1 child under 5 years old, Cough risk was higher in 1-2, 2-3, 3-4 years old, nurseries, caregivers with education level of high school or above, and families with more than 2 children under 5 years old. OR (95% CI) values were 1.52(1.19-1.92), 1.65(1.29-2.10), 1.86(1.36-2.54), 2.59(1.99-3.38), 1.48(1.26-1.74) and 1.35(1.13-1.62), respectively. Further analysis of the influencing factors of different states of cough, multivariate logistic regression model analysis results showed that preschool status, the number of children under 5 years old in the family and the education level of caregivers were the influencing factors of acute, prolonged and chronic cough. Age was only an influencing factor of acute and persistent cough. Conclusions:The disease burden of cough in children under 5 years old community was heavy, and the cough was related to children′s age, education level of caregivers, number of children under 5 years old in the family and childcare status.
9.Safety and immunogenicity analysis of recombinant (hansenula polymorpha) hepatitis B vaccine (CpG ODN adjuvant) among adults: the preliminary results of phase I clinical trial
Zhenzhen LIANG ; Yan SHAO ; Shenyu WANG ; Chuanfu YAN ; Bo CHEN ; Jun ZHANG ; Yingping CHEN ; Xiaosong HU ; Huakun LYU
Chinese Journal of Preventive Medicine 2020;54(8):854-860
Objective:To evaluate the safety and immune effect of recombinant hepatitis B vaccine (CpG ODN adjuvant).Methods:On Oct. 26, 2016, we launched volunteer recruitment in Kaihua county, Quzhou city, Zhejiang Province. In the randomized, double-blind, controlled trial, a total of 48 subjects with negative HBV screening tests and normal hepatorenal function among 18 and 60 years old were selected and divided into two groups randomly, 24 cases each. The experimental group was given 250 μg of CpG ODN recombinant (Hansenula polymorpha) Hepatitis B vaccine and the control group was given 10 μg of commercial Hepatitis B vaccine with timed at 0, 1and 6 months. The inoculation reactions were compared the difference between the two groups after observed and recorded in time periods. We also collected serum before and after immunization to compare the two groups of anti-HBs positive rate, geometric mean concentration(GMC).Results:During the study period, the incidence of adverse events was 66.67%(16/24) in the experimental group and 54.17%(13/24) in the control group, with no significant difference( P=0.556). The severities of adverse events were level 1 or level 2, and no level 3 or above adverse reactions occurred. After full-course immunization, in the FAS data set, the anti-HBs GMC in the experimental group [2 598.56(1 127.90-5 986.90) mIU/ml] was higher than that in the control group[371.97(164.54-840.91) mIU/ml] In the PPS set, the GMC of test group was 7 808.21(3 377.00-18 052.00) mIU/ml, which was higher than that of the control group [843.22(213.80-3 325.90) mIU/ml]. The anti-HBs positive rate of FAS(PPS) was 95.83%(100.00%) in the experimental group and the control group; The anti-HBs strongly positive rate of FAS(PPS) was 79.17%(90.00%) in the experimental group and 33.33%(50.00%) in the control group, with statistically significant differences among the FAS set( P=0.003) and no statistically significance differences among the PPS set( P=0.074). Conclusion:CpG Hepatitis B Vaccine is safe and shows better immunogenicity than the control vaccine.
10.Predominant serotypes and VP1 gene analysis of Echovirus from viral encephalitis children in Quzhou area of Zhejiang province
Xiaofeng QIU ; Guoping CAO ; Jincao PAN ; Guozhong ZHANG ; Jun LI ; Bingdong ZHAN ; Shuchang CHEN ; Huakun LYU
Chinese Journal of Experimental and Clinical Virology 2020;34(2):169-174
Objective:To investigate the predominant serotypes and diversification of Echovirus (ECHOV) from viral encephalitis children in Quzhou area of Zhejiang province and the molecular characteristics of the ECHOV VP1 genes.Methods:Cerebrospinal fluid samples from 53 children with viral encephalitis were collected for viral isolation/culture. Fluorescent RT-PCR or PCR was used to detect human enteroviruses (HEV) including ECHOV, coxsackievirus(CoV) and new enterovirus (EV), and japanese encephalitis virus(JEV), mumps virus(MuV), west Nile virus(WNV) and chikungunya virus(CHLKV) or herpes simplex virus(HSV) and cytomegalovirus(CMV) in the cerebrospinal fluid samples. The complete VP1 gene sequence of HEV-B group in the HEV-positive cerebrospinal fluid samples was amplified by RT-PCR and sequenced, and then the typing of Echovirus isolates was performed. The VP1 genotypes of Echovirus isolates, gene recombination, inheritance and evolution characteristics were analyzed using multiple bioinformatic software.Results:Six viral strains were isolated by cell culture using rhabdomyosarcoma (RD) cells but not human epithelial-2 (Hep-2) cells. Eleven cerebrospinal fluid samples were positive for HEV by RT-PCR but the detection result of all the other viruses were negative. In the 11 HEV-positive samples, 6 samples were positive for ECHOV (4 for ECHO6, 1 for ECHO7 and 1 for ECHO30 serotype), which was coincident with the isolation result , but CoV and EV were undetectable. The 4 ECHO6 isolates belonged to ECHO6-C2 subgenotype but can be divided into two epidemic clones (ECHO6-41/46 and ECHO6-45/48). The ECHO7 and ECHO30 isolates belonged to ECHO7-C and ECHO30-C genotypes. The VP1 gene recombination between the ECHO6 and ECHO30 isolates were found during their evolutionary process.Conclusions:ECHOV is the major pathogen of viral encephalitis children in the area, and there is a possibility of local outbreak or epidemic. Because of the possibility of recombination of the VP1 gene of ECHO6 and ECHO30 virus, ECHO6 may become the dominant ECHOV serotype.

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