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 ; Enzyme-Linked Immunosorbent Assay ; Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology ; Haemophilus influenzae type b/*immunology ; Humans ; Infant ; Korea ; Polysaccharides, Bacterial/administration & dosage/*adverse effects/*immunology ; Tetanus Toxoid/administration & dosage/*adverse effects/*immunology

The recent research papers in ion-sensitivity in-situ gel were reviewed on the following aspects: the characteristics of the gel, the polymer, preparation technology as well as the applications of optical, nasal, and oral route of administration. The solution-gel property of transformation of in-situ gel, which has simple preparation, convenient operation, strong affinity and enough retention time with affected part, especially with mucosa. The recent research advances in ion-sensitivity in-situ gel were mainly reviewed from the following aspects: the characteristics of the gel, the polymer, preparation technology as well as the applications of optical, nasal, and oral route of administration. The present problems of in-situ gel and prospective applications in traditional Chinese medicine were also discussed.
Alginates ; chemistry ; Animals ; Drug Administration Routes ; Drug Delivery Systems ; methods ; Gels ; chemistry ; Humans ; Ions ; chemistry ; Medicine, Chinese Traditional ; Polysaccharides, Bacterial ; chemistry

OBJECTIVETo probe into immunological mechanisms and clinical therapeutic effect of acupoint-injection of BCG polysaccharide nuclear acid (BCG-PSN) for treatment of condyloma acuminatum (CA).

METHODSTwo hundred cases were randomly divided into 4 groups. After removed the CA by laser, the treatment group (group A) was treated with acupoint-injection of BCG-PSN, the control group I (group B) with intramuscular injection of BCG-PSN, the control group II (group C) with intramuscular injection of interferon, and the blank control group (group D) with no treatment. The levels of cellular immune function were detected before treatment and after treatment of 6 months, and the cases of relapse were recorded.

RESULTSThe cured rate of 94.3% in the group A was significantly higher than 78.0% in the group B, 80.4% in the group C and 78.2% in the group D, with significant differences (P < 0.05); in the group A, CD4+ percent increased, CD8+ percent decreased, CD4+ /CD+ ratio increased, and NK cell activity increased with a low relapse rate, and with significant differences as compared with the control groups (P < 0.05, P < 0.01).

CONCLUSIONAcupoint-injection of BCG-PSN has a better therapeutic effect and it can obviously reduce the recurrence rate of CA. The cellular immunoregulatory action is one of the mechanisms of this therapy in preventing relapse of CA.

Acupuncture Points ; Adolescent ; Adult ; BCG Vaccine ; administration & dosage ; CD4-CD8 Ratio ; Condylomata Acuminata ; immunology ; therapy ; Female ; Humans ; Injections ; Killer Cells, Natural ; immunology ; Male ; Middle Aged ; Nucleic Acids ; administration & dosage ; Polysaccharides, Bacterial ; administration & dosage

Salmonella Typhi capsular polysaccharide vaccines were encapsulated in the Micro-particles made from polyethylene glycol-poly-DL-lactide (PELA). BALB/c mouse were divided into three groups with 20 mice in each. Mouse were immunized respectively with controlled release microencapsulated Salmonella Typhi capsular polysaccharide vaccines and Salmonella Typhi capsular polysaccharide vaccines by oral and subcutaneous administration. The mice blood and salvia were collected at the 2nd, 4th and 8th weeks respectively for the titrating of IgG and sIgA antibodies by RIA. At the 8th week, live typhoid bacteria were injected into the immunized mice for the calculation of the rate of immunization protection. The IgG titers of the controlled release microencapsulated Salmonella Typhi capsular polysaccharide vaccines group were higher than those of the other groups(P < 0.05). The IgA titers of the low groups of controlled release microencapsulated Salmonella Typhi capsular polysaccharide vaccines (oral and subcutaneous) were higher than those of the group of Salmonella Typhi capsular polysaccharide vaccines (P < 0.05). The immunization protection rates of the three groups were 40%, 100% and 60% respectively. The controlled release microencapsulated Salmonella Typhi capsular polysaccharide vaccines possess the advantages of releasing slowly in vivo and persisting long time immunogenicity.
Administration, Oral ; Animals ; Delayed-Action Preparations ; Female ; Immunoglobulin A, Secretory ; analysis ; Immunoglobulin G ; blood ; Injections, Subcutaneous ; Mice ; Mice, Inbred BALB C ; Microspheres ; Polysaccharides, Bacterial ; administration & dosage ; immunology ; Typhoid-Paratyphoid Vaccines ; administration & dosage ; immunology ; Vaccination

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 Agglutination Tests ; Animals ; Bacterial Vaccines/administration & dosage ; Cattle ; Cattle Diseases/immunology/microbiology ; Female ; Mastitis, Bovine/*microbiology ; Polysaccharides, Bacterial/*classification/isolation & purification ; Serotyping/methods/veterinary ; Staphylococcal Infections/immunology/*veterinary ; Staphylococcus aureus/*classification/*immunology/isolation & purification

OBJECTIVETo evaluate the safety of meningococcal group AC bivalent polysaccharide conjugate vaccine among children aged 5-24 months old.

METHODSFrom July 2011 to June 2012, a total of 34 411 children aged 5-24 month-old who voluntarily vaccinated meningococcal group AC bivalent polysaccharide conjugate vaccine in Zhongshan city were included. The adverse effects within 72 hours were recorded and analyzed.

RESULTS34 411 children were recruited, including 18 708 boys (54.36%), whose mean age were ( 11.4 ± 3.9 ) months old.Within 72 hours, the incidence rates of local adverse effects were 0.76% (261/34 411) for erythema,0.57% (197/34 411) for sclerosis,0.56% (191/34 411) for swelling,0.42% (143/34 411) for pain,0.15% (53/34 411) for pruritus, and 0.15% (50/34 411) for rash on the injection site. The overall incidence rate of local adverse effects was 1.61% (554/34 411; 95%CI:1.48%-1.74%). The incidence rates of systemic adverse effects were 0.98% (312/34 411) for fever,0.48% (164/34 411) for anorexia,0.31% (108/34 411) for diarrhea,0.29% (100/34 411) for malaise,0.20% (70/34 411) for nausea and vomiting, and 0.08% (26/34 411) for headache. The overall incidence rate of systemic adverse effects was 1.64% (565/34 411; 95%CI:1.51%-1.78%).25 children (0.07%) had hyperpyrexia ( > 39°C), and the time of duration lasted less than 48 hours.16 children (0.05%) had symptoms of cold, such as cough and catarrh.No accident and other serious events were reported. The incidence rate of systemic adverse effects among boys was 1.79% (334/18 708), which was higher than that of girls (1.47%, 231/15 703), the difference showed statistical significance (χ(2) = 5.22, P < 0.01). The incidence rate of systemic adverse effects among children aged 5-12 month-old was 1.78% (411/23 113), which was higher than that among children aged 13-24 month-old (1.36%, 154/11 298), the difference showed statistical significance (χ(2) = 8.10, P < 0.01). The incidence rate of local adverse effects in children vaccinated the first dose was 1.72% (536/31 129), which was higher than that in children vaccinated the second or third dose (0.55%, 18/3282), the difference showed statistical significance (χ(2) = 25.81, P < 0.01). The incidence rate of systemic adverse effects in children vaccinated the first dose was 1.73% (539/31 129), which was higher than that in children vaccinated the second or third dose (0.79%, 26/5282), whose difference also showed statistical significance (χ(2) = 16.22, P < 0.01).

CONCLUSIONThe safety of meningococcal group AC bivalent polysaccharide conjugate vaccine among children aged 5-24 months old is relative good.

Female ; Humans ; Infant ; Male ; Meningitis, Meningococcal ; microbiology ; prevention & control ; Meningococcal Vaccines ; administration & dosage ; adverse effects ; immunology ; Neisseria meningitidis, Serogroup A ; Neisseria meningitidis, Serogroup C ; Polysaccharides, Bacterial ; immunology ; Vaccines, Conjugate ; administration & dosage ; adverse effects ; immunology

OBJECTIVETo describe the design and application of cluster randomized controlled method on typhoid Vi vaccine trial, and to assess the effect of implementation.

METHODSSimple size calculation of cluster-randomized trial was used to determine the sample size of the two groups and a vaccination campaign was conducted. The study group was given typhoid Vi vaccine and the control group was given meningococcal A vaccine.

RESULTSAccording to sample size calculation, a total sample of 96,121 participants was required and the study areas were divided into 108 clusters. In practice, 53 study clusters with 44,054 participants and 54 control clusters with 48,422 participants were stratified and matched according to size, location (urban or rural), characteristics (school, department, factory, demography) were randomized respectively. Confounding factors of two groups including age, sex, resident area, income, level of education were compared. It was found that the ratio of all confounding factors between the two groups were comparable and balanced.

CONCLUSIONConfounding factors can be better controlled between study group and the control group by applying cluster-randomized method on vaccine trail which enabled the intervention to be more scientifically evaluated; The implementation of cluster randomization trial was simple and easy to be accepted.

Adolescent ; Adult ; Child ; Child, Preschool ; China ; Cluster Analysis ; Female ; Humans ; Male ; Mass Vaccination ; organization & administration ; Middle Aged ; Polysaccharides, Bacterial ; immunology ; Typhoid Fever ; prevention & control ; Typhoid-Paratyphoid Vaccines ; immunology ; Vaccination

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 ; Antibodies, Bacterial/immunology ; Antigens, Bacterial/*immunology/*isolation&purification ; Blotting, Western ; Enzyme-Linked Immunosorbent Assay ; Lethal Dose 50 ; Logistic Models ; Male ; Mice ; Mice, Inbred BALB C ; Polysaccharides, Bacterial/*immunology/*isolation&purification ; Salmonella typhi/chemistry/*immunology ; Typhoid Fever/immunology/prevention&control ; Typhoid-Paratyphoid Vaccines/administration & dosage/*immunology/*isolation&purification

BACKGROUNDAtopy is a state of allergy to common antigens and is founded on an immune disturbance of exuberant Th2 activity and IgE production. There is also epidemiological and experimental evidence that exposure to mycobacteria has the potential to suppress the development of asthma or atopy. Since Th1 and Th2 immune mechanisms are significantly antagonistic, it is hypothesized that mycobacterial exposure may moderate atopic disease by modification of immune responses.

METHODSOne hundred and twenty mild to moderate persistent asthmatics accompanied with allergic rhinitis were randomly divided into four groups with one injection every other day for 18 times for group A with 1 ml of normal saline, B with 0.5 mg of Bacillus Calmette-Guérin polysaccharide nucleotide (BCG-PSN) and C with 1 mg of BCG-PSN, 36 times for group D with 0.5 mg of BCG-PSN. Markers for the severity of asthma and rhinitis including the amount of inhaled corticosteriod, bronchodilator and oral H1 blocker-loratidine being used to obtain optimal symptomatic control, symptom scores of asthma and allergic rhinitis, peak expiratory flow (PEF), histamine provocative dose that produces at least a 20% change in forced expiratory volume with in 1 second (PD20-FEV1), blood IgE levels as well as dermatophagoides pteronysinus (DP) and dermatophagoides farinae (DF) skin prick test were measured every visit for 6 months.

RESULTSThere were no differences for symptom scores of asthma, daily use of bronchodilator, PEF, PD20-FEV1, blood IgE as well as DF and DP skin prick test among the four groups. Score for allergic rhinitis decreased significantly in groups B, C and D on day 36 and 72 as compared with group A (P < 0.05). Score for allergic rhinitis increased after day 72 in group B and C while it was significantly lower in group D (P < 0.05). The patients in group D used less amount of inhaled beclomethosone than other groups (P < 0.05) from day 72 after the treatment to day 180. Oral loratadine consumption in groups B, C and D was significantly less on day 36 and 72 as compared with their baseline and group A after the treatment (P < 0.05). Group D maintained significantly lower dosage of oral loratadine until day 150 comparing with its baseline and group A.

CONCLUSIONSBCG-PSN has a symptomatic effect on allergic rhinitis. BCG-PSN may reduce the dosage of non-sedative H1 blocker loratadine as well as the dosage of inhaled beclomethosone in the treatment of mild to moderate asthma and allergic rhinitis.

Adult ; Asthma ; immunology ; therapy ; BCG Vaccine ; administration & dosage ; Double-Blind Method ; Female ; Humans ; Immunoglobulin E ; blood ; Injections, Intramuscular ; Interferon-gamma ; biosynthesis ; Male ; Middle Aged ; Nucleotides ; administration & dosage ; Polysaccharides, Bacterial ; administration & dosage ; Rhinitis, Allergic, Perennial ; immunology ; therapy ; Rhinitis, Allergic, Seasonal ; immunology ; therapy ; Skin Tests

The in situ gel systems can form gel in situ after administration to achieve sustained release, thus provides a promising strategy for drug delivery systems. The aim of this study was to design and prepare in situ gel systems for the oral delivery of ibuprofen (IBU-ISG) and study its pharmacokinetics in Beagle dogs. The characteristics of the basic material of gellan gum (Kelcogel, Kel) and sodium alginate (Manugel, M) were studied through investigating the complex viscosity of the Kel or M solution with or without different concentrations of calcium ion or sodium citrate to ascertain the amount range of the excipients. The measurement of complex viscosity of the solution (0. 5% Kel and 1% M) with different concentrations of sodium citrate and calcium ion was carried out to select the suitable proportion of calcium ion and sodium citrate. The formulation of binary IBU-ISG was optimized by monitoring the complex viscosity before gelling in vitro release property. The optimized formulation contains 1.0% sodium alginate, 0.5% gellan gum, 0. 21% sodium citrate and 0.056% calcium chloride. A single oral dose of IBU-ISG and reference formulation (IBU suspension) were given to each of the 6 healthy Beagle dogs, ibuprofen in plasma at different sampling times was determined by RP-HPLC. The pharmacokinetics parameters in 6 Beagle dogs were calculated. The Tmax of IBU-ISG and reference formulation were (1.8 +/- 0.6) and (0.4 +/- 0. 1) h. The Cmax values were (29.2 +/- 7.6) and (37.8 +/- 2.2) microg x mL(-1). The T(1/2) were (2.3 +/- 0.5) and (2.0 +/- 0.9) h, and the AUC(0-t) were (131.0 +/- 38.6) and (117.3 +/- 23.1) microg x mL(-1) x h, respectively. The binary IBU-ISG was successfully prepared.
Administration, Oral ; Alginates ; chemistry ; Analgesics, Non-Narcotic ; administration & dosage ; blood ; pharmacokinetics ; Animals ; Area Under Curve ; Calcium Chloride ; chemistry ; Citrates ; chemistry ; Delayed-Action Preparations ; Dogs ; Drug Compounding ; methods ; Drug Delivery Systems ; Excipients ; Female ; Glucuronic Acid ; chemistry ; Hexuronic Acids ; chemistry ; Ibuprofen ; administration & dosage ; blood ; pharmacokinetics ; Male ; Polysaccharides, Bacterial ; chemistry ; Viscosity