1.Application of lysis system in bacterial vector vaccines.
Yibo TANG ; Qing LIU ; Pei LI ; Hongyan LUO ; Qingke KONG
Chinese Journal of Biotechnology 2019;35(3):375-388
Recombinant bacterial vector vaccines have been widely used as carriers for the delivery of protective antigens and nucleic acid vaccines to prevent certain infectious diseases because of their ability to induce mucosal immunity, humoral immunity and cellular immunity. However, protective antigens and nucleic acids recombined into bacterial vector vaccines are difficult to be released into host cells because of the presence of bacterial cell wall. Vaccine strains that are residual in animals or livestock products may also cause environmental contamination and spread of the vaccine strains. The effective solution for these problems is to construct an auto-lysis system that can regulate the vaccine strains to grow normally in vitro while lysis in vivo. The lysis systems that have been applied in germs mainly include: the lysis system based on regulated delayed peptidoglycan synthesis, the lysis system based on the regulation of bacteriophage lysis protein and the lysis system based on the toxin-antitoxin system. In addition, a potential lysis system based on bacterial Type Ⅵ Secretion System (T6SS) is also expected to be a new method for the construction of auto-lysis strains. This review will focus on the regulatory mechanisms of these bacterial lysis systems.
Animals
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Antigens, Bacterial
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Bacterial Vaccines
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Vaccines, Attenuated
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Vaccines, DNA
2.Chemical components analysis and morphology observation of virus in Japanese encephalitis vaccine produced from Beijing strain
Journal of Practical Medicine 2005;0(6):3-5
The first 5 lots of Japanese encephalitis vaccines produced from Beijing-1 strain: JB011203, JB021203, JB030104, JB040204 and JB050304 were controlled of quality on chemical components and virus morphology in vaccine, using reference vaccine EJP034A (BIKEN-Japan). The results showed that: TCA-protein was 13.2- 14.5 µg/ml, the reference was 11.1 µg/ml (WHO standard 5-40 µg/ml). The thimerosal content was 82-84 µg/ml, the reference 76,3 µg/ml (WHO standard ≤120 µg/ml). The formaldehyde content was 0.061-0.063 µg/ml, the reference was 2.19 µg/ml (WHO standard ≤100 µg/ml). pH was 7.02-7.04, the reference was 7.10 (WHO stand. 6.8-7.4). The viruses morphology after negative stain were observed on electromicroscope JEM1010 with enlarge x 90.000 and x 150.000. The identical ball form of purified viruses with the intact surface antigen. 5/5 lots were passed the minimum requirements of biological products of WHO.
Japanese Encephalitis Vaccines
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Antigens
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Bacterial
5.Pneumonia vaccine trials at Tari.
Papua and New Guinea medical journal 2002;45(1-2):44-50
Pneumonia is the commonest cause of death of children in Papua New Guinea (PNG). At Tari pneumonia is most commonly caused by Streptococcus pneumoniae and Haemophilus influenzae, which set up rapid severe infections in the lungs that require urgent treatment. In rural PNG, however, treatment is often delayed. Penicillin-resistant forms of these bacteria are on the increase. It is therefore important to have another means of protection against this serious disease. This paper describes three field trials of a vaccine against the commonest serotypes of S. pneumoniae found in PNG. The trials show that a pneumococcal vaccine can prevent deaths from uncomplicated acute lower respiratory tract infection in small children and adults. It is likely that the vaccine does this by limiting the replication of bacteria in the lungs and thus limiting their spread to other parts of the body.
Vaccines
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Pneumonia
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g <3>
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limitin
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Bacterial
6.Development of a reference substance for live bacterial count of Streptococcicosis live vaccines.
Lingxiang XIN ; Xiuli WANG ; Wenjing LV ; Lianna ZANG ; Dongmei ZHU ; Ying LUO ; Yuan ZHANG ; Xiaoning LI ; Bo LIU ; Junping LI
Chinese Journal of Biotechnology 2021;37(7):2554-2562
This study attempts to develop a reference substance for the live bacteria count of Streptococcicosis live vaccines in order to evaluate the validity of live bacterial count in inspection and testing. We prepared a batch of live Streptococcus suis reference substance for live bacterial count, tested their physical property, purity, vacuum degree, remaining moisture, and determined their homogeneity, thermal stability and transportation stability. Moreover, we organized collaborative calibration to assign count values to the reference substance and determine the shelf life of the reference substance in 12 months. The results showed that the physical property, the purity, the remaining moisture and the vacuum degree of the reference substance were all in compliance with the requirements of the Chinese Veterinary Pharmacopoeia. The homogeneity test showed that the coefficient of variation of the count of the reference substance was less than 10%, indicating a good homogeneity. Transportation stability test showed that the reference substance remained active after 72 h transportation in summer and winter with the package of styrofoam boxes and ice packs. Thermal stability test showed that the reference substance could be stored for up to 3 months at -20 °C, or up to 21 days at 4 °C. According to the collaborative calibration, the reference vaccine was assigned a count value range of (8.5-12.1)×107 CFU/ampoule. The shelf life test showed that the reference substance was stable for 12 months when stored at -70 °C. The reference substance could provide a reference for the live bacterial count of Streptococcicosis live vaccines. Moreover, it could also be used as a reference to evaluate the quality of corresponding agar media.
Bacterial Load
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Reference Standards
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Vaccines, Attenuated
7.Microneedle patches for vaccine delivery.
Hyemee SUH ; Juhyung SHIN ; Yeu Chun KIM
Clinical and Experimental Vaccine Research 2014;3(1):42-49
In today's medical industry, the range of vaccines that exist for administration in humans represents an eclectic variety of forms and immunologic mechanisms. Namely, these are the live attenuated viruses, inactivated viruses, subunit proteins, and virus-like particles for treating virus-caused diseases, as well as the bacterial-based polysaccharide, protein, and conjugated vaccines. Currently, a new approach to vaccination is being investigated with the concept of DNA vaccines. As an alternative delivery route to enhance the vaccination efficacy, microneedles have been devised to target the rich network of immunologic antigen-presenting cells in the dermis and epidermis layers under the skin. Numerous studies have outlined the parameters of microneedle delivery of a wide range of vaccines, revealing comparable or higher immunogenicity to conventional intramuscular routes, overall level of stability, and dose-sparing advantages. Furthermore, recent mechanism studies have begun to successfully elucidate the biological mechanisms behind microneedle vaccination. This paper describes the current status of microneedle vaccine research.
Antigen-Presenting Cells
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Bacterial Vaccines
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Dermis
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Epidermis
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Humans
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Skin
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Vaccination
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Vaccines
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Vaccines, DNA
8.Nitroblue Tetrazolium Reduction by Pseudoeosinophils from Rabbits Treated with Bacterial or Viral Vaccine.
Sang Ghern CHUNG ; Jong Wo SHIN
Journal of the Korean Pediatric Society 1979;22(8):671-680
This study was undertaken to acquire some information concerning the mechanism for reduction of nitroblue tetrazolium (NBT) dye by neutrophils. Male rabbits weighing more than 2 kilograms were used in this study. The vaccines. The vaccines utilized were bacterial and viral ones such as typhoid, cholera, measles, and mumps vaccines. The histochemical NBT test was carried out using the method by Park et al. With some modification. Vaccines were given the rabbits, and changes were observed in the percentage and number of pseudoeosinophils and NBT-positive pseudoeosils in the peripheral blood. The data obtained thus were discussed and summarized as follow:1. The percentage of the NBT-positive pseudoeosinophils increased in the rabbits to which the bacterial vaccines were given. 2. The percentage of NBT-positive pseudoeosinophils decreased in the rabbits to whick viral vaccines were given. 3. No association was found between the percentage of the NBT-positive pseudoeosinophils and the number of pseudodosinophils following the administeration.
Bacterial Vaccines
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Cholera
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Humans
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Male
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Measles
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Mumps
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Neutrophils
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Nitroblue Tetrazolium*
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Rabbits*
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Typhoid Fever
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Vaccines
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Viral Vaccines
9.Effects of Addition of Sugars on the Stability of Leptospira Vaccine.
Korean Journal of Infectious Diseases 1998;30(6):551-557
BACKGROUND: Most of the current licensed viral and bacterial vaccines produced in the world are in the state of antigen suspension, and the immunogenicities of the vaccines can be maintained for one to two years at 4 degrees C, but without refrigeration vaccines easily lose their immunogenicities. METHODS: In this study, as an attempt to improve the stability and maintenancee of the immunogenicity of the vaccines at room termperature or at higher temperatures, sucrose, lactose and glucose were added into the leptospira vaccines respectively, and kept at 37 degrees Cfor 1, 3, 5, and 7 days. The vaccines were inoculated twice into Sprague Dawley rats after 7 days' interval and the titers of the antibodies against the antigen of Leptosp ira icterohemorrhagiae in the sera from rats were measured. Results were evaluated by logistic regress analysis (SAS/PC). RESULTS: Sera from rats inoculated with the normal contol vaccine kept at 4 degrees Cfor 7 days showed antibody titers of 1:20 ~80. The vaccine without sugar exposed at 37 degrees Cfor one day nearly lost its immunogenicity. And the vaccine contained sucrose could keep the immunogenicity at least for 7days at 37 degrees C(p=0.001), though the titers were slightly lower than the titer of normal control. Stabilities of lactose and glucose were lower than sucrose. CONCLUSION: Addition of sucrose, lactose and glucose could increase the stability of leptospira vaccine. 7.5% and 10% sucrose in vaccine could maintain the immunogenicity of leptospira vaccine for 7 days at 37 degrees C. This method is expected to be applied to the production of other viral and bacterial vaccines.
Animals
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Antibodies
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Bacterial Vaccines
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Carbohydrates*
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Glucose
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Lactose
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Leptospira*
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Rats
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Rats, Sprague-Dawley
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Refrigeration
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Sucrose
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Vaccines
10.A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants
Zhiqiang XIE ; Dongyang ZHAO ; Haitao HUANG ; Jinbo GOU ; Wei ZHANG ; Yongli YANG ; Lili HUANG ; Yanxia WANG ; Xue WANG ; Lifeng XU ; Tao ZHU ; Shengli XIA
Chinese Journal of Preventive Medicine 2020;54(9):947-952
The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
Antibodies, Bacterial
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Humans
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Infant
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Meningococcal Vaccines
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adverse effects
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immunology
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Vaccines, Conjugate