1.Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of China.
Yue Xin XIU ; Lin TANG ; Fu Zhen WANG ; Lei WANG ; Zhen LI ; Jun LIU ; Dan LI ; Xue Yan LI ; Yao YI ; Fan ZHANG ; Lei YU ; Jing Feng WU ; Zun Dong YIN
Biomedical and Environmental Sciences 2025;38(9):1032-1043
OBJECTIVE:
The objective of our study was to evaluate the vaccine effectiveness (VE) of the pentavalent rotavirus vaccine (RV5) among < 5-year-old children in three provinces of China during 2020-2024 via a propensity score-matched test-negative case-control study.
METHODS:
Electronic health records and immunization information systems were used to obtain data on acute gastroenteritis (AGE) cases tested for rotavirus (RV) infection. RV-positive cases were propensity score matched with RV-negative controls for age, visit month, and province.
RESULTS:
The study included 27,472 children with AGE aged 8 weeks to 4 years at the time of AGE diagnosis; 7.98% (2,192) were RV-positive. The VE (95% confidence interval, CI) of 1-2 and 3 doses of RV5 against any medically attended RV infection (inpatient or outpatient) was 57.6% (39.8%, 70.2%) and 67.2% (60.3%, 72.9%), respectively. Among children who received the 3rd dose before turning 5 months of age, 3-dose VE decreased from 70.4% (53.9%, 81.1%) (< 5 months since the 3rd dose) to 63.0% (49.1%, 73.0%) (≥ 1 year since the 3rd dose). The three-dose VE rate was 69.4% (41.3%, 84.0%) for RVGE hospitalization and 57.5% (38.9%, 70.5%) for outpatient-only medically attended RVGE.
CONCLUSION
Three-dose RV5 VE against rotavirus gastroenteritis (RVGE) in children aged < 5 years was higher than 1-2-dose VE. Three-dose VE decreased with time since the 3rd dose in children who received the 3rd dose before turning five months of age, but remained above 60% for at least one year. VE was higher for RVGE hospitalizations than for medically attended outpatient visits.
Humans
;
Rotavirus Vaccines/immunology*
;
China/epidemiology*
;
Case-Control Studies
;
Child, Preschool
;
Infant
;
Rotavirus Infections/epidemiology*
;
Male
;
Propensity Score
;
Female
;
Vaccine Efficacy
;
Gastroenteritis/virology*
;
Vaccines, Attenuated
;
Rotavirus
2.Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.
Kong Boo PHUA ; Fong Seng LIM ; Seng Hock QUAK ; Bee Wah LEE ; Yee Leong TEOH ; Pemmaraju V SURYAKIRAN ; Htay Htay HAN ; Hans L BOCK
Annals of the Academy of Medicine, Singapore 2016;45(2):44-50
INTRODUCTIONThis was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life.
MATERIALS AND METHODSHealthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed.
RESULTSOf 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups.
CONCLUSIONTwo oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.
Antibodies, Viral ; immunology ; Double-Blind Method ; Female ; Gastroenteritis ; prevention & control ; virology ; Humans ; Immunogenicity, Vaccine ; Immunoglobulin A ; immunology ; Infant ; Male ; Rotavirus ; immunology ; Rotavirus Infections ; prevention & control ; Rotavirus Vaccines ; immunology ; therapeutic use ; Singapore ; Treatment Outcome ; Vaccines, Attenuated ; immunology ; therapeutic use
3.Detection of Rotavirus Genotypes in Korea 5 Years after the Introduction of Rotavirus Vaccines.
Ju Young CHUNG ; Min Sung KIM ; Tae Woong JUNG ; Seong Joon KIM ; Jin Han KANG ; Seung Beom HAN ; Sang Yong KIM ; Jung Woo RHIM ; Hwang Min KIM ; Jae Hong PARK ; Dae Sun JO ; Sang Hyuk MA ; Hye Sook JEONG ; Doo Sung CHEON ; Jong Hyun KIM
Journal of Korean Medical Science 2015;30(10):1471-1475
Rotavirus (RV) is one of the most important viral etiologic agents of acute gastroenteritis (AGE) in children. Although effective RV vaccines (RVVs) are now used worldwide, novel genotypes and outbreaks resulting from rare genotype combinations have emerged. This study documented RV genotypes in a Korean population of children with AGE 5 yr after the introduction of RVV and assessed potential genotype differences based on vaccination status or vaccine type. Children less than 5-yr-old diagnosed with AGE between October 2012 and September 2013 admitted to 9 medical institutions from 8 provinces in Korea were prospectively enrolled. Stool samples were tested for RV by enzyme immunoassay and genotyped by multiplex reverse-transcription polymerase chain reaction. In 346 patients, 114 (32.9%) were RV-positive. Among them, 87 (76.3%) patients were infected with RV alone. Eighty-six of 114 RV-positive stool samples were successfully genotyped, and their combinations of genotypes were G1P[8] (36, 41.9%), G2P[4] (12, 14.0%), and G3P[8] (6, 7.0%). RV was detected in 27.8% of patients in the vaccinated group and 39.8% in the unvaccinated group (P=0.035). Vaccination history was available for 67 of 86 cases with successfully genotyped RV-positive stool samples; RotaTeq (20, 29.9%), Rotarix (7, 10.4%), unvaccinated (40, 59.7%). The incidence of RV AGE is lower in the RV-vaccinated group compared to the unvaccinated group with no evidence of substitution with unusual genotype combinations.
Child, Preschool
;
Feces/virology
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Gastroenteritis/immunology/prevention & control/virology
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Genotype
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Humans
;
Infant
;
*Mass Vaccination
;
RNA, Viral/genetics
;
Republic of Korea
;
Reverse Transcriptase Polymerase Chain Reaction
;
Rotavirus/*classification/*genetics/isolation & purification
;
Rotavirus Infections/immunology/*prevention & control/virology
;
Rotavirus Vaccines/*immunology
;
Vaccines, Attenuated/immunology
4.Advances in Correlation between Rotaivrus and Histo-blood Group Antigens.
Dandi LI ; Sun XIAOMAN ; Zhaojun DUAN
Chinese Journal of Virology 2015;31(4):463-467
Group A rotaviruses (RVs) are major pathogens associated with acute gastroenteritis in young children and animals worldwide. VP4 is responsible for interaction with the host and viral attachment. Recent study showed that the distal portion of rotavirus (RV) VP4 spike protein (VP8*) is implicated in binding to human histo-blood group antigens (HBGAs), which is new cellular receptors on rotavirus, Published in Nature and Journal of Virology in 2012. The paper describes advances in correlation between rotaivrus and HBGAs, summarizes the main achievements has gotten, Clarify the significance of study on Rotaivrus and HBGAs.
Animals
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Blood Group Antigens
;
genetics
;
immunology
;
Genetic Variation
;
Humans
;
Rotavirus
;
immunology
;
physiology
;
Rotavirus Infections
;
blood
5.Phylogenetic Analyses and Characterization of the VP7 Genes of Serotype G9 Rotaviruses Circulating in Nanjing (China), 2012-2013.
Xuan WANG ; Limin SHI ; Mengkai QIAO ; Yan WANG ; Min HE ; Wei YONG ; Xuefei DU ; Baofu GUO ; Guoxiang XIE ; Ziqian XU ; Jie DING
Chinese Journal of Virology 2015;31(4):425-432
Group-A rotaviruses are recognized as the most common cause of acute diarrhea. Phylogenetic analyses of the VP7 genes of rotaviruses circulating in Nanjing (China) could aid in the development of rotavirus vaccines. A total of 908 stool specimens were collected from patients suffering from acute diarrhea in Nanjing between October 2012 and December 2013, and were tested further for rotaviruses. Fifty rotavirus isolates selected randomly were typed by reverse transcription-polymerase chain reaction using serotype-specific primers for G genotyping. VP7 genes of 19 G9 strains were sequenced for further genetic characterization. Among the 908 stool specimens examined during the surveillance period, 103 (11.34%) were rotavirus-positive. G9 was the most predominant genotype (78.0%), followed by G2, G1 and G3. Sequence and phylogenetic analyses of the VP7 genes of serotype G9 rotaviruses revealed these strains to comprise two lineages (G9-VI, G9-III) and to be dominated by the G9-VI lineage (which belonged to a unique subcluster of Japanese and Chinese G9 strains). Amino-acid sequences of the four antigenic regions (A, B, C or F) were variant among a portion of strains, which may have contributed to the prevalence of G9 rotaviruses in this area.
Adult
;
Amino Acid Sequence
;
Antigens, Viral
;
chemistry
;
genetics
;
Capsid Proteins
;
chemistry
;
genetics
;
China
;
Evolution, Molecular
;
Humans
;
Infant
;
Molecular Sequence Data
;
Mutation
;
Phylogeny
;
Rotavirus
;
genetics
;
immunology
;
physiology
;
Serogroup
6.Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples.
Jayoung KIM ; Hyun Soo KIM ; Han Sung KIM ; Jae Seok KIM ; Wonkeun SONG ; Kyu Man LEE ; Sunhwa LEE ; Kyoung Un PARK ; Woochang LEE ; Young Jun HONG
Annals of Laboratory Medicine 2014;34(3):216-222
BACKGROUND: We evaluated the analytical and clinical performances of the SD BIOLINE Rota/Adeno Rapid kit (SD Rota/Adeno Rapid; Standard Diagnostics, Inc., Korea), an immunochromatographic assay (ICA), for the simultaneous detection of rotaviruses and adenoviruses in human stool samples. METHODS: We tested 400 clinical stool samples from patients with acute gastroenteritis and compared the ICA results with the results obtained by using ELISA, enzyme-linked fluorescent assays (ELFA), PCR, and multiplex reverse transcription-PCR (mRT-PCR). To assess the analytical performance of the SD BIOLINE Rota/Adeno Rapid kit, we determined its detection limit, reproducibility, cross-reactivity, and analytical reactivity for adenovirus subtypes, and performed interference studies. RESULTS: The overall agreement rates among the tested methods were 91.5% for rotavirus and 85.5% for adenovirus. On the basis of mRT-PCR, the overall agreement, positive agreement, and negative agreement rates of the ICA were 95.6%, 100%, and 94.9% for rotavirus, and 94.0%, 71.4%, and 94.8% for adenovirus, respectively. Using the ICA, we detected all the subtypes of adenovirus tested, but the analytical reactivities for adenovirus subtypes were different between the 4 adenovirus detection methods. The high reproducibility was confirmed, and no cross-reactivity or interference was detected. CONCLUSIONS: The SD BIOLINE Rota/Adeno Rapid kit showed acceptable analytical and clinical performances. However, interpretation of adenovirus positive/negative result should be cautious because of different detectability for adenovirus subtypes among adenovirus detection methods.
Acute Disease
;
Adenoviridae/genetics/*immunology/isolation & purification
;
Cross Reactions
;
DNA, Viral/analysis
;
Enzyme-Linked Immunosorbent Assay
;
Feces/*virology
;
Gastroenteritis/diagnosis/virology
;
Humans
;
*Immunochromatography
;
Multiplex Polymerase Chain Reaction
;
RNA, Viral/analysis
;
Reagent Kits, Diagnostic
;
Reproducibility of Results
;
Reverse Transcriptase Polymerase Chain Reaction
;
Rotavirus/genetics/*immunology/isolation & purification
7.Changes in Anti-Group A Rotavirus Antibody Seroprevalence and Levels in the Western Gyeongnam Province of Korea Over 16 Years.
Ji Hyun SEO ; Jung Je PARK ; Jae Young LIM ; Jin Su JUN ; Chan Hoo PARK ; Hyang Ok WOO ; Hee Shang YOUN ; Young Cheol KWON ; Hyung Lyun KANG ; Seung Chul BAIK ; Woo Kon LEE ; Myung Je CHO ; Kwang Ho RHEE ; Wonyong KIM
Journal of Korean Medical Science 2013;28(1):55-61
To observe how anti-group A rotavirus antibody seropositivity rates and levels have changed in the western region of Gyeongnam Province, 2,030 serum samples collected at four collection periods (1989-1990, 1994-1995, 1999-2000, and 2004-2005) were tested by Enzyme-Linked Immunosorbent Assay for IgG, and IgA antibodies reacting to recombinant VP6 protein. The seroprevalences exhibit no regular patterns over a 16-yr period. For all four collection periods, the anti-rVP6 IgG levels rose steadily during the first 5 months of life, after which they remained high. However, the 2-9 yr and 10-39 yr groups had significantly higher IgG levels in 1999-2000 and 2004-2005, respectively, than in the other collection periods. The 1-5 mo, 40- > or = 60 yr, and 4-29 yr groups had significantly higher IgA levels in 1989-1990, 1999-2000, and 2004-2005, respectively. The 4 yr (25.0%), 5-9 yr (18.8%), 10-14 yr (41.1%), 20-29 yr (35.0%), and 30-39 yr (20.0%) groups in 2004-2005 had significant higher IgA seropositivity rate compared to the other three collection periods. These observations suggest that in the western region of Gyeongnam Province since the late 1990s, rotavirus reinfection has occurred more frequently than previously, with all ages being at risk.
Adult
;
Aged
;
Antibodies, Viral/*blood
;
Antigens, Viral/genetics/immunology/metabolism
;
Capsid Proteins/genetics/immunology/metabolism
;
Child
;
Child, Preschool
;
Enzyme-Linked Immunosorbent Assay
;
Female
;
Humans
;
Immunoglobulin A/blood
;
Immunoglobulin G/blood
;
Infant
;
Infant, Newborn
;
Male
;
Middle Aged
;
Recombinant Proteins/biosynthesis/genetics/immunology
;
Republic of Korea/epidemiology
;
Rotavirus/isolation & purification/*metabolism
;
Rotavirus Infections/*epidemiology/virology
;
Seroepidemiologic Studies
;
Time Factors
;
Young Adult
8.Study on genetic transformation of antigen G3VP7 gene of human rotavirus in peanut.
Yuchen JIA ; Kai ZHAO ; Xin XUE ; Wei LI ; Shaowei LI ; Dehu LIU
Journal of Biomedical Engineering 2012;29(2):328-331
In order to increase the expression level of target gene and to simplify the purifying process of separation and purification, we performed the transgenetic research of antigen VP7 gene into peanut via Agrobacterium tumefaciens. The plant binary expression vector is pBOG3VP7 harboring fusion gene oleosin-vp7, which is promoted by ole-promoter. Cotyledon nodes were used as transformation recipients. Transformed individuals were obtained through selection on medium containing 125 mg L-1 Kan. Integration of transgenes was assessed by PCR amplification and PCR-Southern blot hybridization. Taking pBOG3VP7 plasmid as positive control, non-transformed peanut as negative control. 6 plants among 11 plants grown up through seletion medium were detected by PCR and the rate of positive plants is 54.5%. PCR positive plants were further analysed by PCR-Southern blot hybridization. The results showed that 3 plants have DNA bloting bands. The results also showed that the foreign gene was integrated into genome of transformed peanuts. Elevated expression of rotavirus VP7 antigen in transgenic peanuts was a critical factor in the development of efficient and cheap plant oral vaccine.
Agrobacterium tumefaciens
;
genetics
;
Antigens, Viral
;
biosynthesis
;
genetics
;
Arachis
;
genetics
;
metabolism
;
Capsid Proteins
;
biosynthesis
;
genetics
;
Plants, Genetically Modified
;
genetics
;
metabolism
;
Rotavirus
;
genetics
;
immunology
;
Transformation, Genetic
;
Vaccines, Synthetic

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