1.The difference for quantity of nucleotide and amino acid between human rotavirus strain \u2013 Vietnam candidate for rotavirus vaccine production and international standard wild strains.
Luan Thi Le ; Hien Dang Nguyen
Journal of Preventive Medicine 2008;18(6):61-66
Background: Rotavirus induced diseases is most commonly seen in children between 6 and 36 months old. In developing countries, rotavirus is also a common cause of gastrointestinal inflammation in below 2 years old children. Study on production of vaccine strains is a target that the World Health Organization is providing. Objective: To determine the quantity of different nucleotide and amino acids of genes 4, 6, 9, 10 of the Vietnam seed lot system and vaccine G1P8, G1P4 and G4P6. Subject and methods: By sequence method determine the quantity of different nucleotide and amino acids of gene 4 (VP4), gene 6 (VP6), gene 9 (VP7) and gene 10 (NSP4) of the Vietnam seed lot system and vaccine G1P8 (KH0118), G1P4 (2001019210) and G4P6 (2001019203) in comparison with international standard wild strains such as Ku, DS1, ST3, Hochi, TB-chen. Results and Conclusion: Each strain had a different nucleotide and amino acid sequence and it was characterized by each country. However, these strains had the same general chemical components including nucleic acid and protein. Nucleic acid was a double fiber ARN with 11 genes, and 18 thousand base pairs. 3 proteins with specific antigens were VP4, VP6 and VP7. 57 nucleotide of gene 4 (VP4) of the seed lot system G1P8 were different with Ku (AB22772) strain but there were only 17 different amino acids. For gene 7 (VP7), 70 nucleotide were different between G1P8 strain and Ku (AB222784) strain but there were 15 different amino acids. For gene 6 (VP6), although 141 nucleotide were different between G1P8 strain and Ku (AB222784) strain but there were only 9 different amino acids. For gene 10 (NSP4), 62 nucleotide were different between G1P8 strain and Ku strain (AB222772), making 12 different amino acids.
rotavirus vaccine
2.Preparation of local reference BCG vaccine
Journal of Preventive Medicine 2003;13(6):19-24
Nha Trang National Institute of Vaccine had produced successfully BCG vaccine of local norm standard (5mg/ampulla) met the criterion issued by Hanoi National Centre of biopreparation quality control. Living units: 3.33 0.51 x 106 units; rate of thermo-stability 78.8 4.7%; photo density 0.23 0.018; dispersive density 1.11 0.075 and residual humidity 215 0.21%
BCG Vaccine
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Vaccines
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immunization
3.Stability of freeze - dried BCG vaccine
Journal of Preventive Medicine 2003;13(6):25-28
BCG vaccine produced by Nha Trang Institute of Vaccine has reached a high stability, after 36 months of preserve at the temperature of 4oC, the quality criteria were guaranteed with the mean living level of 1.76 0.62 x 106 living units/mg (with survival rate of 59.68%). The validity of this vaccine from 24 months increasing to 30 months was recommended
BCG Vaccine
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Vaccines
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immunization
4.Control of residual SO42- content in puried sera
Journal of Preventive Medicine 2003;13(6):94-96
A survey conducted on 15 consecutive lots of purified sera showed that SO2-4 content in hydrolyzed fluid as satisfying the requirement, then was quantified as small value in purified sera. However, among the lots of high SO2-4 content in purified sera (SAR 12,13, SAT 13,14), it was always lower than 0.15g/l. In comparing with the SO4 standard of China’s SAT; 1g/l, the SO4 content of our preparation was 7 times lower purified sera
BCG Vaccine
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Biology
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Vaccines
5.Production of pertussia vaccine in fermentor D.300 # 00171/99 at IVAC
Journal of Preventive Medicine 2003;13(6):10-14
4 lots of DPT mixte vaccine were produced with whooping-cough vaccine concentrated fluid by fermentor D300. The product was reached WHO and Hanoi National Controlled Centre criterion of safety and efficacy
Antigens, Bacterial
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Pertussis Vaccine
6.Assessment on Quality of single polio vaccine type 1 produced on primary monkey cells.
Dung Mai Dang ; Hien Dang Nguyen ; Luan Thi Le
Journal of Preventive Medicine 2007;17(3):26-29
Background: \r\n', u'October 2000, Vietnam was acknowledged as the country to successfully eradicate the polio by WHO.This success was partly due to the oral polio vaccine (OPV) produced on the primary money cells by the Centre of Research, Production of vaccines and biologicals, Ha Noi. In 2006, the Centre developed the single polio vaccine type 1 from primary monkey cells.\r\n', u'Objectives: \r\n', u'To evaluate the safety and antibody titre .\r\n', u'Subjects and method: \r\n', u'6 lots of single polio vaccine type 1 (ISO- 90, Antibodies of Polio type 1,2,3; the standard sample F113 from Japanese research on Polio Institute\ufffd?\r\n', u'Using the tests (T- maker, D maker, PFU, CCID50) to check the safety of single polio vaccine type 1. \r\n', u'Results:\r\n', u'After 14 days, 6/6 lots of viruses were observed via the microscope that they stayed in well developed, and of no serious adverse affects.There was no appearance of degenerated cells. \r\n', u'Conclusion:\r\n', u'6/6 lots of single polio vaccine type 1 produced on Macca mulltta monkey kidney cells with the first time passage at POLYVAC in 2006 are safe and high antibody titre.\r\n', u'
Poliovirus Vaccine
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Oral
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7.Determining the potency of measles vaccine using plaque method
Hien Dang Nguyen ; Thu Nu Anh Nguyen
Journal of Preventive Medicine 2007;17(5):24-28
Background: Measles vaccine was the only vaccine in the expanded vaccination program still must be imported. Center for research and production of vaccines and biologicals \ufffd?Ha Noi was conducting the first stages of measles vaccine manufacturing technology transfer from the Kitasato Institute in Japan. The Center received semi-finished vaccine to set up finished vaccine production process as well as the testing process. Potency test and its consistency is very essential in quality control. Objectives: In order to identify standard potency assessment methods and potency of 13 lots of finished measles vaccine produced in Viet Nam from imported semi-finished products. Subjects and method: 13 lots of the finished vaccine were determined potency by plaque method based on 13 samples of semi-finished vaccine and the standard sample M16-6 had potency from 4.2 to 4.6 lg PFU/0.5 ml provided by the Kitasato Institute. Results: The result of 13 lots show that the reduction of potency during freeze-drying is within the range (0-0.76 lg); and 4 last consecutive lots are met WHO criteria on heat stability. Conclusion: This shows that the measles vaccine freeze-drying process in Vietnam was officially set up to use for the measles vaccine production in 2007.
Measles Vaccine/ diagnostic use
8.Stable study of gene sequence of seed lot system G1P4 (2001019210) during production of rotavirus vaccine
Luan Thi Le ; Hien Dang Nguyen ; Huong Thi Mai Nguyen
Journal of Preventive Medicine 2008;18(6):5-11
Background: Presently, toxicity decreased oral live rotavirus is a candidate for vaccine for the prevention of rotavirus induced diarrhea. According to the World Health Organization, the seed lot system is robustly checked, in which determining the stable of gene sequence. Objective: To determine the sequence of genes 4: 6: 9: 10 with base pair correlative 855: 824: 1314: 734 of seed lot system G1P4 (2001019210) during production of rotavirus vaccine. Subject and methods: Gene 4 (VP4), gene 6 (VP6), gene 9 (VP7) and gene 10 (NSP4) of seed lot system G1P4 were determined for gene sequencing and then comparing the nucleotide sequence as well as deduced amino acids from original strain with the produced strain and vaccine virus. Results and Conclusion: There was no different for nucleotide and deduced amino acid sequence from the original strain during the production of rotavirus vaccine of G1P4 MS (2001019210) to producing strains of G1P4 WS and vaccine strains of G1P4 VX.
rotavirus vaccine
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gene sequence
9.Establishment of the National references for Sabin vaccine produced in Vietnam
Journal of Practical Medicine 2002;435(11):44-46
A study on the establishment of the effective standard for the national standard samples of vaccine of single vaccine type 1, 2 and 3 and triple vaccine (Sabin) produced in Vietnam was carried out. The sesults have shown that the National standard sample had a high unified and stable properties that meet the requirement of the world health organization (WHO). The National standard sample were used to evaluate the quality of sabin vaccine produced in Vietnam which showed that 450 batches (100%) sabin vaccine produced in the scientific center for the vaccine production during 1995-1999 obtained the standard of WHO.
Poliomyelitis
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Poliovirus Vaccine, Oral
10.The relation between oral immunization with poliomyelitis vaccine and the evolution of poliomyelitis epidemic in North Vietnam
Journal of Practical Medicine 2002;435(11):33-34
All children in suspicion of poliomyelitis from 28 provinces of North Vietnam (from 1993 to 1999) were enrolled in study performed with a form of inquiry concerning all related personal health documents and reports. Results shown that all children suffered from poliomyelitis with isolated wild poliovirus accounted for 73.4% were primarily non-immunized or under-dose-immunized. Conclusion recommended the continuation of oral immunization among all under-one year old children in combining with the providing two doses of oral vaccine per year for under five years old children
Poliomyelitis
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Poliovirus Vaccine, Oral