1.Study on the safety and immunogenicity of group A + C meningococcal polysaccharide vaccine.
Li HE ; Rong-cheng LI ; Ya-nan LI ; Yun-neng HUANG ; Qun YAO ; Zeng-lin YUAN ; Feng-xiang LI ; Xuan-lin CUI ; Yi NONG ; Ming YANG
Chinese Journal of Epidemiology 2007;28(5):422-425
OBJECTIVEIn order to evaluate the safety and immunogenicity of group A + C meningococcal polysaccharide vaccine, a controlled field trial was performed among children at 6-24 months and 5-13 years old in Longsheng county, Guangxi Zhuang Autonomous Region.
METHODSMore than 600 children were selected in this trial. 428 children, aged 6-24 month-old and 5-13 year-old were involved in two experimental groups and were inoculated 100 microg of group A + C meningococcal polysaccharide vaccine. 103 children in positive control group were inoculated 50 microg of group A meningococcal polysaccharide vaccine while 94 children in negative control group were inoculated 30 microg of Typhoid Vi polysaccharide vaccine. Both systemic and local reactions were observed in each group at 6 h,24 h,48 h and 72 h after inoculation. Blood samples were collected in all children before and at 1 month after inoculation. Additionally, at least 50 blood samples were taken in each experimental group at 6 and 12 months after inoculation. Serum bactericidal antibody was tested by micro bactericidal test.
RESULTSBoth systemic and local reactions were mild in two experimental groups with only 3 children (0.7%) had > or = 37. 6 degrees C fever, 4 children (0.9%) appeared mild areola but all adverse reaction disappeared within 48 hours. In 5-13 year-old experimental group, the rates for four-fold increase of bactericidal antibody were 96.59% and 92.15% to group A and group C meningococcus respectively at 1 month after inoculation, and remained 90.91% and 90.08% at 12 months after inoculation.
CONCLUSIONGroup A + C meningococal polysaccharide vaccine was safe and having good immunogenicity among Chinese children.
Adolescent ; Antibodies, Bacterial ; blood ; immunology ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Meningococcal Vaccines ; adverse effects ; immunology ; Polysaccharides, Bacterial ; adverse effects ; immunology ; Typhoid-Paratyphoid Vaccines ; adverse effects ; immunology
2.Immunogenicity of Vi capsular polysaccharide vaccine evaluated for three years in Korea.
Yang Ree KIM ; Jin Hong YOO ; Jae Kyun HUR ; Jin Han KANG ; Wan Shik SHIN ; Moon Won KANG
Journal of Korean Medical Science 1995;10(5):314-317
The immunogenicity of a single dose of Salmonella typhi(S.typhi) Vi capsular polysaccharide(CPS) vaccine was evaluated before, and at 1, 3, 12, and 36 months after vaccination. Eighty-five adults(20-28 years of age) and sixty-four children(8-16 years of age) received a single dose of 25 micrograms Vi CPS vaccine intramuscularly, and antibody titers to Vi CPS were measured by passive hemagglutination. Of 149 vaccinees, 138(92.6%) showed seroconversion at 1 month after vaccination, and then 138 out of 141(97.9%) did at 3 months. Of 137 vaccinees, 116(84.7%) maintained a persistent rise in Vi antibody titer 12 months after vaccination, and 55 out of 100(55.0%) had a 4-fold or greater rise at 36 months. No significant adverse reactions were observed. Booster injection may be needed 3-5 years after vaccination.
Adolescent
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Adult
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Antibodies, Bacterial/blood
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Antigens, Bacterial/immunology
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Child
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Evaluation Studies
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Human
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Polysaccharides, Bacterial/*immunology
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Salmonella typhi/*immunology
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Typhoid Fever/prevention & control
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Typhoid-Paratyphoid Vaccines/adverse effects/immunology/*therapeutic use
3.Immunogenicity and Safety of Two Different Haemophilus influenzae Type b Conjugate Vaccines in Korean Infants.
Kyung Hyo KIM ; Hyunju LEE ; Eun Hee CHUNG ; Jin Han KANG ; Jong Hyun KIM ; Jung Soo KIM ; Hoan Jong LEE ; Sung Hee OH ; Eun Ae PARK ; Su Eun PARK
Journal of Korean Medical Science 2008;23(6):929-936
The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of > or = 1.0 microgram/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.
Bacterial Outer Membrane Proteins/administration & dosage/*adverse
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Enzyme-Linked Immunosorbent Assay
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Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
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Haemophilus influenzae type b/*immunology
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Humans
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Infant
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Korea
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Polysaccharides, Bacterial/administration & dosage/*adverse effects/*immunology
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Tetanus Toxoid/administration & dosage/*adverse effects/*immunology
4.Peptide Mimotopes of Neisseria meningitidis Group B Capsular Polysaccharide.
Inho PARK ; In Hong CHOI ; Se Jong KIM ; Jeon Soo SHIN
Yonsei Medical Journal 2004;45(4):755-758
The antigenic similarity between Neisseria meningitidis group B (NMGB) capsular polysaccharide (PS) and human polysialic acid (PSA) has hampered the development of a NMGB PS-based vaccine. But the possibility of a safe vaccine based on NMGB PS has been demonstrated by the existence of the NMGB PS-associated nonautoreactive epitope, which is distinct from those present on human PSA. To obtain peptide mimotopes of NMGB PS, we used HmenB3, a protective and nonautoreactive monoclonal antibody, to screen a phage library with 12 amino acids. We obtained 23 phage clones that bound to HmenB3 but not in the presence of E. coli K1 PS [which is alpha (2-8) -linked PSA like NMGB PS]. The clones contained 3 mimotopes and differed from previously described NMGB PS mimotopes. Immunization with a synthetic peptide of one mimotope elicited anti-NMGB antibodies in BALB/c mice. These mimotopes may be useful in the development of group B meningococcal vaccines.
Amino Acid Sequence
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Animals
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Bacterial Vaccines/*immunology
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Cloning, Molecular
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Female
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Meningococcal Infections/*immunology/*prevention & control
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Mice
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Mice, Inbred BALB C
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Molecular Sequence Data
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Neisseria meningitidis, Serogroup B/genetics/*immunology
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Polysaccharides, Bacterial/genetics/*immunology
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Research Support, Non-U.S. Gov't
5.Extraction and purification of the Klebsiella pneumoniae capsular polysaccharide and the effection on the cell immunoactivity.
Yan ZHANG ; Qing-Zhou LI ; Lian-Xiang DU ; Wei QI ; Jin-Ying CHEN
Chinese Journal of Biotechnology 2005;21(3):461-465
Klebsiella pneumoniae was cultured followed by the preparation and immunoactivity elucidating of its polysaccharide (CPS). The lysis of cell is the first key step in the preparation, under the co-action of trypsin, lysozyme and NP-40, the cell lysed within 2h, then the lysate was concentrated by ultrafiltration which serves as concentrating and partial purifying action simultaneously. Crude CPS was got by ethanol precipitation, then purified through the Ion-exchange and gel filtration, the purity of CPS was judged by the gel filtration and agarose gel electrophoresis. The effect of CPS on the cell immunoactivity was studied in detail, the results show that CPS possesses bidirectional immunoregulation on the spleen cells of mice, that is, low concentration of CPS can stimulate the immune response while the high concentration manifests the inhibition significantly. The investigation results will benefit on the exploitation of the CPS.
Animals
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Bacterial Capsules
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chemistry
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Culture Media
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Klebsiella pneumoniae
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chemistry
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immunology
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Lymphocyte Activation
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drug effects
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immunology
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Lymphocytes
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immunology
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Mice
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Mice, Inbred BALB C
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Polysaccharides, Bacterial
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immunology
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isolation & purification
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Spleen
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cytology
6.Evaluation on the safety of a group A + C meningococcal polysaccharide vaccine.
Bai-qing DONG ; Qiang YE ; Xuan-lin CUI ; Jin YANG ; Jian GONG ; Ming YANG ; He-zhuang LIAO ; Shi-liang WEI ; Jie ZHANG ; Xing-hua WU ; Guo-ai SI ; Hong-hui YANG ; Ataru TSUZUKI ; JinKyung PARK ; Mohammad ALI ; Leon R OCHIAI ; John D CLEMENS
Chinese Journal of Epidemiology 2007;28(5):417-421
OBJECTIVETo evaluate the safety of a group A + C meningococcal polysaccharide vaccine as part of a phase IV clinical trial.
METHODSThe study area was divided into 108 clusters according to the principle of cluster randomization, stratified and paired sampling methods. 54 out of 108 clusters served as observation groups were administered A + C vaccine, while the rest 54 groups were administered Vi polysaccharide vaccine. An adverse event surveillance system was established to monitor the adverse events following the vaccination campaign. Identical form and methods were used for data collection to investigate the adverse events following the vaccination of both A+ C vaccine and Vi vaccine.
RESULTS34,543 people were vaccinated, including 18,167 of whom received A + C vaccine, while the other 16,376 received Vi vaccine. The rates of immediate injection reaction and unsolicited non-serious adverse events from A + C vaccine group were 0.44% and 0.38% while of Vi vaccine group were 0.79% and 0.73% respectively. At the solicited adverse event survey on 3-day-post-vaccination, 1239 vaccinees were followed-up including 771 received A + C vaccine and 468 received Vi vaccine. The local injection reaction rate of A + C vaccine group on the 1st day was significantly higher (X2 = 13.98, P = 0.0002) than that of Vi vaccine group. Neither the local injection reaction rate nor the system reaction rate between both groups was significantly different on 2nd and 3rd day, post vaccination. It was not statistically different when comparing fever onset rate between those who received vaccine and those who did not, in each vaccine group. There were no serious adverse events observed.
CONCLUSIONResults showed that the side effects of A + C vaccine and the Vi vaccine were mild and safe for vaccination campaigns targeting on populations at different age.
Adolescent ; Adult ; Age Distribution ; Child ; Child, Preschool ; Female ; Humans ; Male ; Meningococcal Vaccines ; adverse effects ; immunology ; Middle Aged ; Polysaccharides, Bacterial ; immunology ; Sex Distribution ; Young Adult
7.Reaction of the sera of the Korean children free from Hib invasive diseases against H. influenzae type B capsular polysaccharide antigen.
Kyung Hyo KIM ; Dong Soo KIM ; Moon Sung PARK ; K T KIM ; Hyun Sook KIM ; Kyoung Hee KIM ; Oh Hun KWON
Journal of Korean Medical Science 1994;9(1):1-8
The purpose of our experiment is to examine the level of anti-Haemophilus influenza polysaccharide antibody titer in the Korean population. Using ELISA, the level of Hib-PS antibodies in 384 infants and children who were all free from Hib invasive diseases, was tested. And the blood of 50 mothers within 24 hours of delivery and cord blood from their respective full-term neonates was also tested. The transport of Hib-PS IgG and IgG subclasses in paired sera from mothers and neonates was also measured. The titer of Hib-PS IgG varies with age. At birth the mean optical density of cord blood was 1.028; however, it declined to 0.609 up to 6 months and further decline was noted up to 2 years to 0.488. Then the mean O.D. remained around 0.5 from 3 to 14 years of age. The mean O.D. of Hib-PS IgG in the mothers blood was 0.856. The ratio of mean O.D. of anti-Hib PS IgG antibody in the cord blood to that in the maternal blood was 1.20. The mean optical densities of IgG subclasses were: 1.18 for anti-Hib PS IgG1, 1.07 for anti-Hib PS IgG2, 1.01 for anti-Hib PS IgG3, and 1.09 for anti-Hib PS IgG4. The sera from Korean children of almost all age groups reacted to Hib-PS antigen on ELISA. Also the active transport of anti-Hib PS IgG antibody through placenta was observed. Among four IgG subclasses, only IgG1 transport had significant experimental meaning.
Adolescent
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Adult
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Antibodies, Bacterial/*immunology
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Antigens, Bacterial/*immunology
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Bacterial Capsules
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Child
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Child, Preschool
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Enzyme-Linked Immunosorbent Assay
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Female
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Fetal Blood/immunology
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Haemophilus Vaccines/*immunology
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Haemophilus influenzae/*immunology
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Humans
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Immunoglobulin G/classification/immunology
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Infant
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Infant, Newborn
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Korea
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Male
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Maternal-Fetal Exchange
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Polysaccharides, Bacterial/*immunology
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Pregnancy
8.Capsular polysaccharide typing of domestic mastitis-causing Staphylococcus aureus strains and its potential exploration of bovine mastitis vaccine developmen. I. capsular polysaccharide typing, isolation and purification of the strains.
Hong Ryul HAN ; Son Il PAK ; Seung Won KANG ; Woo Seog JONG ; Cheol Jong YOUN
Journal of Veterinary Science 2000;1(1):53-60
One hundred seven isolates of Staphylococcus aureus from bovine mastitis were investigated for colony morphology in serum-soft agar (SSA), autoagglutination in salt, and capsular serotype. Capsular polysaccharide (CP) was purified and quantified from the extracts of clinical isolates. Overall, 89 isolates (83.2%) were diffuse in the SSA, without any difference in the proportion of diffuse colony between type 5 and type 8 strains. Some strains exhibited compact colonies in the SSA and expressed CP as determined by an enzyme-linked immunosorbent assay, indicating that compact morphology does not exclude encapsulation. The majority of the strains (11/12) showed autoagglutination in the salt aggregation test. The serotype 336 accounted for 46.7% of the isolates followed by serotype 5 (12.1%) and serotype 8 (12.1%). Particularly, twenty-six (24.3%) isolates reacted with two serotypes; 7 for type 8/336 and 19 for type 5/336. Five isolates (4.7%) were nontypeable with monoclonal antibodies specific for CP serotype 5, 8, or 336. The CP concentration in culture supernatants varied with the serotypes, and the total amount of CP produced by cells grown in a liquid medium was much less than that produced by cells grown on a solid medium. The Western blotting indicated that the CP bands of S. aureus serotype 5 and 8 were ranged in the molecular mass of 58-84 kilodalton (kDa), with additional bands in the region of approximately >or= 48 or
9.Evaluation of antibody responses to pneumococcal vaccines with ELISA and opsonophagocytic assay.
Journal of Korean Medical Science 1999;14(5):475-479
Antibodies to a capsular polysaccharide (PS) provide protection against Streptococcus pneumoniae which express the homologous capsular serotype, and pneumococcal vaccines are designed to induce antibodies in the capsular PS. Levels and opsonophagocytic capacity of antibodies to the capsular PS of S. pneumoniae serotype 19F were determined by sera from adults immunized with 23-valent S. pneumoniae capsular PS vaccines. Geometric means of IgG anti-19F antibody level and specific opsonic titer rise significantly after immunization. The level of anticapsular PS antibodies for S. pneumoniae 19F serotype is fairly well correlated (r2=O.63) with the opsonophagocytic activities of sera. However, 3.7% (1/27) of serum samples display strikingly less opsonophagocytic activity than expected on the basis of their antibody level. Thus, antibody level may be of general use in predicting vaccine-induced protection among adults for 19F serotype. However, the opsonic activity data suggest that antibody levels are not always indicative of functional antibody.
Adult
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Antibody Formation
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Bacterial Vaccines/immunology*
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Enzyme-Linked Immunosorbent Assay
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Human
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IgG/blood*
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Opsonins/blood*
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Phagocytosis/immunology
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Pneumococcal Infections/prevention & control*
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Pneumococcal Infections/immunology*
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Pneumococcal Vaccines
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Polysaccharides/blood
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Reference Values
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Serotyping
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Streptococcus pneumoniae/immunology
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Streptococcus pneumoniae/classification
10.Efficacy of Purified Vi Polysaccharide Typhoid Vaccine.
Jong Hwan PARK ; Jung Joo HONG ; Eun Sil CHOI ; Jin Won LEE ; Jae Hak PARK
Journal of Veterinary Science 2002;3(2):67-70
This experiment was conducted to assess the efficacy of typhoid vaccine newly produced by purifying Vi antigen of Salmonella typhi. With Karber method, LD50 of challenging organism (S. typhi ty2) was determined as 6.31 CFU/mouse, and then the organism was used for the study. With Probits method, ED50 of the vaccine was determined as 0.016 microgram / 0.5 ml / mouse. The ELISA titer (0.5097+/-0.0606) was 4 times in the group treated with high dose (0.25 microgram/0.5ml) as in control (0.1113+/-0.0110). Six major protein bands of 66, 55, 35, 33, 18, and 9 kd were detected in Western blot analysis with serum of a vaccine treated mouse, whereas only one weak band of about 35 kd was detected with serum of a control mouse. We concluded that typhoid vaccine produced by purifying Vi antigen of S. typhi very effectively prevent S. typhi infection in mice.
Animals
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Antibodies, Bacterial/immunology
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Antigens, Bacterial/*immunology/*isolation&purification
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Blotting, Western
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Enzyme-Linked Immunosorbent Assay
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Lethal Dose 50
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Logistic Models
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Male
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Mice
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Mice, Inbred BALB C
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Polysaccharides, Bacterial/*immunology/*isolation&purification
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Salmonella typhi/chemistry/*immunology
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Typhoid Fever/immunology/prevention&control
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Typhoid-Paratyphoid Vaccines/administration & dosage/*immunology/*isolation&purification