1.Safety and potency of rotavirus master seed G4P6 (2001019203)
Luan Thi Le ; Hien Dang Nguyen
Journal of Preventive Medicine 2007;17(5):15-19
Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain. Thanks to the help of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G4P6 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G4P6 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G4P6 (2001019203) lot 1 (MS-PL5) and lot 2 (MS-PL5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G4P6 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The results were the basis of Rota vaccine production in Vietnam.
Rotavirus/ isolation &
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purification
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Rotavirus Vaccines/ isolation &
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purification
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contraindications
2.Safety and potency of rotavirus master seed G1P4 (2001019210)
Journal of Preventive Medicine 2007;17(5):42-46
Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain.Thanks to the helps of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G1P4 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G1P4 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G1P4 (2001019210) lot 1 (MS-P5) and lot 2 (MS-P5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G1P4 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The result was the basis of Rota vaccine production in Vietnam.
Rotavirus/ diagnostic use
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Rotavirus Vaccines/ isolation &
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purification
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contraindications
3.Genotype of Rotavirus Vaccine Strain LLR in China is G10P15.
Dandi LI ; Ziqian XU ; Guangcheng XIE ; Hong WANG ; Qing ZHANG ; Xiaoman SUN ; Nijun GUO ; Lili PANG ; Zhaojun DUAN
Chinese Journal of Virology 2015;31(2):170-173
Rotavirus is the leading causal agent of severe acute gastroenteritis in children aged <5 years. A specific pharmacologic agent for the treatment of rotavirus-infected children is lacking. In China, only the Luo Tewei oral vaccine (Lanzhou Institute of Biological Products, Shanghai, China), which is produced from Lanzhou lamb rotavirus vaccine (LLR), is available. Studies have hypothesized that the genotype of LLR is G10P[12], To identify the genotype of LLR by reverse transcription-polymerase chain reaction, we showed that the VP7 and VP4 genotypes of LLR were G10 and P[15], respectively, based on sequencing, alignment and phylogenetic analyses. In conclusion, we identified the genotype of rotavirus strain LLR to be G10P[15].
China
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Genotype
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Humans
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Molecular Sequence Data
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Phylogeny
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Rotavirus
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chemistry
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classification
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genetics
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isolation & purification
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Rotavirus Infections
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virology
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Rotavirus Vaccines
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chemistry
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classification
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genetics
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isolation & purification
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Sequence Homology, Amino Acid
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Viral Proteins
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chemistry
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genetics
4.Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study.
Kong Boo PHUA ; Seng Hock QUAK ; Fong Seng LIM ; Paul GOH ; Yee Leong TEOH ; Sanjoy Kumar DATTA ; Htay Htay HAN ; Hans Ludwig BOCK
Annals of the Academy of Medicine, Singapore 2008;37(7):546-553
INTRODUCTIONIn recent years, acellular pertussis combination vaccines have facilitated compliance with and coverage of the national immunisation programme in Singapore. This phase-II study (Rota-007) evaluated the immunogenicity, reactogenicity and safety of a DTPa-IPV/Hib combined vaccine when co-administered with a rotavirus vaccine.
MATERIALS AND METHODSA total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 ratio of either placebo (n=653) or 1 of 3 different formulations of a rotavirus vaccine. Blood samples were collected for immunogenicity analysis 1 month after the third DTPa-IPV/Hib vaccine dose in a subset of subjects (n = 640). Local and general reactogenicity and unsolicited adverse events were recorded during the follow-up after each vaccination.
RESULTSSerological analysis showed >95% response for all antigens in the co-administered DTPa-IPV/Hib vaccine, with no difference between the rotavirus vaccine and placebo groups. No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups. Only 0.2% of the subjects reported Grade 3 adverse events. Three subjects (from the vaccine groups) died during the study, which were assessed by the investigators as unrelated to vaccination. No deaths were reported in the placebo group.
CONCLUSIONThe combined DTPa- IPV/Hib vaccine is safe, well tolerated and highly immunogenic when given alone or coadministered with the rotavirus vaccine for infants in Singapore.
Child ; Child Welfare ; Child, Preschool ; Double-Blind Method ; Female ; Haemophilus Infections ; immunology ; prevention & control ; Haemophilus influenzae type b ; isolation & purification ; Humans ; Infant ; Infant, Newborn ; Male ; Patient Compliance ; Poliomyelitis ; prevention & control ; Rotavirus Vaccines ; Singapore ; Vaccines, Combined ; Vaccines, Conjugate ; adverse effects ; immunology
5.Analysis on molecular characteristic of VP7 and NSP4.
Yong-Kun HUANG ; Qin QI ; Zong-Liu HOU ; Hai-Lin LI ; Ge-Sheng WEN ; Wei PANG ; Li-Fang ZHOU
Chinese Journal of Epidemiology 2005;26(12):980-983
OBJECTIVETo explore the molecular characteristics and molecular variation of human rotavirus (HRV) strains and to understand the relationship between clinical characteristics and epidemiology of different HRV-VP7 and NSP4.
METHODSDouble-strand RNA of rotavirus extracted from stool samples was used as the template for reverse transcription of gene VP7, which was followed by nested PCR for VP7 typing. NSP4 genes from 22 epidemic strains of human rotavirus isolated in Kunming in 2002 and 2003 were amplified with RT-PCR. Then cDNAs were sequenced and compared with 4 human rotavirus NSP4 (Wa, KUN, AU-1, Hochi)) and 3 animal rotavirus NSP4 (EW, OSU, SA11) available in the GenBank while the epidemic strains of human rotavirus isolated in different areas of China were compared, using the Clustal-mp, DNAssist, MEGA2 software. The G serotype of VP7 was analysed by PCR.
RESULTSSerotype G1 was prevalent in 2002 while serotype G3 was the prevalent in Kumming in 2003. The NSP4 genes from 22 epidemic strains of human rotavirus isolated in Kunming in 2002 and 2003 belonged to Wa with highly conservative amino acid. Samples isolated in the same years but not in the same area shared higher homology. Symptoms associated with heavy diarrhea did not seem to be associated with NSP4 molecular variation (P > 0.05).
CONCLUSIONObvious variations of VP7 typing were seen in the same season, as well as in different areas and years. Due to the stable nature of NSP4, it seem to be a better candidate for vaccine production, than VP7.
China ; DNA, Complementary ; genetics ; DNA, Viral ; Genes, Viral ; Humans ; Polymerase Chain Reaction ; RNA, Double-Stranded ; genetics ; RNA, Viral ; RNA-Directed DNA Polymerase ; Rotavirus ; classification ; genetics ; isolation & purification ; Rotavirus Vaccines ; Sequence Analysis, DNA ; Sequence Homology, Nucleic Acid ; Serotyping
6.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
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Feces/virology
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Gastroenteritis/immunology/prevention & control/virology
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Genotype
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Humans
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Infant
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*Mass Vaccination
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RNA, Viral/genetics
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Republic of Korea
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Reverse Transcriptase Polymerase Chain Reaction
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Rotavirus/*classification/*genetics/isolation & purification
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Rotavirus Infections/immunology/*prevention & control/virology
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Rotavirus Vaccines/*immunology
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Vaccines, Attenuated/immunology