Safety and reactogenicity of a group-A meningoccal polysaccharide vaccine for children 5 to 14

The safety and reactogenicity of group A meningococcal polysaccharide vaccine prepared at the G. N. Gabrichevsky Research Institute for Epidemiology and Microbiology (Moscow) and intended for the immunization of children aged 5-14 years were studied. The data obtained in this study made it possible to characterize the preparation as safe and mildly reactogenic. Shifts in the blood formula registered 24 hours after the injection of the vaccine remained within the limits of physiological fluctuations. Subfebrile temperature persisting for 2 days was registered in some of the children aged 5-8 years. Local reaction in the form of hyperemia at the site of injection was insignificant. The optimum vaccination dose will be determined on the basis of the whole complex of the data presented in this work, as well as the data on the immunological activity of the preparation.     

Reactogenicity of a group A and C meningococcal polysaccharide bivalent vaccine

A total of 1 968 persons aged 18-20 years belonging to organized groups were immunized with different doses of polysaccharide meningococcal divaccine, groups A and C, by means of syringes and jet injectors under the conditions of a controlled epidemiological trial. Systemic reactions to the injection of the preparation were found to be absent. Local reactions manifested by inflammation, swelling and tenderness at the site of injection were faintly pronounced and disappeared in 48 hours, which is indicative of low reactogenicity of the preparation under study.     

The reactogenicity and antigenic activity of a meningococcal group B vaccine made from a natural complex of the specific polysaccharide and outer membrane proteins

Group B meningococcal vaccine consisting of the natural complex of specific polysaccharide and outer membrane protein (OMP) has been shown to be moderately reactogenic, safe with respect to the effect of undermining tolerance to human brain tissue antigens and to produce no allergization of humans. The vaccine under study possesses antigenic activity: (a) immunization with this vaccine ensures the fourfold rise of the level of antibodies to the group-specific polysaccharide of group B meningococcus in about 80% of persons with the initially low level of antibodies, this percentage being retained during the whole period of observation, i. e. 85 days; (b) the vaccine enhances the level of antibodies to meningococcal OMP, determined in the enzyme immunoassay and the passive hemagglutination test; (c) these data are indicative of the expediency of immunizing the risk groups of persons with the initially low level of antibodies.     

Evaluation of the immunological activity and safety of group B meningococcal vaccine prepared from a natural complex of specific polysaccharide and outer membrane proteins

Immunological activity and safety of group B meningococcal vaccine prepared from a natural complex of specific polysaccharide and outer membrane proteins were under study. The immunological safety of the vaccine was evaluated by the absence of antibodies to denaturated and native DNA (d-DNA and n-DNA). As shown with the use of the enzyme immunoassay (EIA), the administration of the vaccine did not induce antibody formation to d-DNA and n-DNA during the observation period. The titer of bactericidal antibodies in the immune bacteriolysis assay (IBA) to the vaccine strain B:2b:P1.2 after immunization increased four-fold and greater in 80% of the vaccinated persons. The significant increase of bactericidal antibodies to heterologous strains B:2a:P1.2 and B:15:P1.7 was registered in 20-30% of the vaccinees, respectively. A month after the repeated vaccination an increase in specific IgG antibodies to the complex antigen was found to occur according to EIA results. The use of RIB made it possible to evaluate the preventive activity of group B meningococcal vaccine as a whole and to suppose that the vaccine induced mainly type-specific response.     

冻干A+C群脑膜炎球菌多糖疫苗安全性和免疫原性观察

为了评价冻干A+C群脑膜炎球菌多糖疫苗(MPV)的安全性和免疫原性,按随机、盲法的原则,评价疫苗免疫后不良反应发生率、抗体阳转率及抗体几何平均滴度(GMT)。将606名健康观察者分为2～5岁、6～12岁、13～17岁、18～60岁四个年龄组,结果显示,该疫苗全身反应发生率2.64%,局部反应发生率1.32%,四个年龄组疫苗免疫后杀菌抗体阳性率分别为100%、100%、99.3%和100%,免疫后A群杀菌抗体GMT分别为1:250.47、1:190.61、1:144.22和1:205.79,免疫后C群杀菌抗体GMT分别为1:273.33、1:551.18、1:788.26和1:809.81,冻干A+C群多糖疫苗在≥2岁人群中具有良好的安全性和免疫原性,建议推广使用A+C群MPV。     

The reactogenicity and immunological efficacy of a Klebsiella vaccine in donors

Klebsiella vaccine, when injected subcutaneously to donors, proved to be faintly reactogenic and safe. The injection of the vaccine had no effect on changes in the morphological composition of peripheral blood and on liver function. In persons with the initially low content of IgG an increase in this characteristic was observed after immunization. No changes in the synthesis of IgE occurred in healthy donors under the influence of immunization. The vaccine was shown to be immunogenic when introduced according to immunization schedules comprising 3 and 5 injections, the titer of Klebsiella antibodies increasing 3- to 5-fold.     

薄膜过滤法在A群C群脑膜炎球菌多糖疫苗无菌检查中的应用

采用薄膜过滤法对A群C群脑膜炎球菌多糖疫苗的无菌检查方法进行验证.结果表明,薄膜过滤法具有取样量大,操作简便,污染几率小,能确保检验结果的准确性、有效性和重现性,该方法适用于A群C群脑膜炎球菌多糖疫苗的无菌检查方法.     

Comparative study of the reactogenicity and immunogenicity of various doses of a chemical polysaccharide meningococcal vaccine administered by syringe and jet injector

The article presents the results obtained in the comparative study of the reactogenicity and immunogenic potency of different doses of chemical polysaccharide meningococcal vaccine, type A, introduced with a syringe and a jet-injector. The preparation has been shown to possess low reactogenicity, high immunogenic potency and to produce a sufficiently pronounced intensity of postvaccinal immunity. The preparation is recommended for wide use in immunization of adults in a dose of 75 micrograms.     

检测四价脑膜炎球菌多糖疫苗中A群多糖含量ELISA法的建立

目的建立双抗体夹心ELISA法,对A群流脑多糖抗原进行特异性定量测定。方法制备抗A群多糖的特异性多克隆抗体,所得抗血清经辛酸-硫酸铵沉淀法纯化后,用过碘酸钠法制备辣根过氧化物酶标记多克隆抗体。分别以抗A群多糖多克隆抗体作为包被抗体及酶标二抗,建立双抗体夹心ELISA法,优化反应条件,对A群多糖抗原进行特异性定量测定。结果一系列验证试验表明,该法特异性较好,未检出与C、Y、W135群多糖的交叉反应;1.25～20 ng/mL多糖浓度范围的剂量反应曲线线性最佳,相关系数大于0.98,经实验内10次及不同试验间以16、84、ng/mL测定3次A群多糖中的含量,变异系数在6.3%～11.5%间,回收率在91.8%～105.9%之间,符合常规质控要求,检测限量为4 ng/mL。采用该法测定3批ACYW135群四价脑膜炎球菌多糖疫苗中A群多糖含量、分子大小及回收率的结果均符合规程草案质量标准。结论建立的双抗体夹心ELISA法可尝试用于ACYW135群脑膜炎球菌多糖疫苗中A群多糖的关键质量指标的检测。     

A群C群脑膜炎球菌结合疫苗稳定性

目的评价A群C群脑膜炎球菌结合疫苗原液和成品的稳定性。方法分别将A群、C群脑膜炎球菌结合疫苗原液及A群C群脑膜炎球菌结合疫苗各选取连续3批,分别放置于37℃、20~25℃和2~8℃3种温度下,在一定的时间取样进行主要项目测定,在关键时间点进行全面检测。结果 A群结合疫苗原液于2~8℃保存9个月,20~25℃保存4周,37℃保存4 d;C群结合疫苗原液于2~8℃保存9个月,20~25℃保存6个月,37℃保存4周;A群C群脑膜炎球菌结合疫苗于2~8℃保存2年3个月,20~25℃保存6个月,37℃可以保存9周;各项检测指标均符合质量标准的要求。结论在2~8℃条件下,A群、C群脑膜炎球菌结合疫苗原液存放6个月,A群C群脑膜炎球菌结合疫苗存放2年,其质量稳定。     

Examining physical activity and inactivity in 9-12 years old children

Information about children's daily physical activity in Eastern-Europe is essential because of the increasing prevalence in overweight and obesity. Sixty-three children (age=11.16 ± 1.10 years; 33 boys and 30 girls) from two public elementary schools had their physical activity objectively measured using uni-axial accelerometer every 5 seconds for five consecutive days (3 weekdays, 2 weekend days). After data cleaning, 10 children were excluded from database. There were no significant differences in boys' and girls' BMI (17.6 ± 2.2 vs. 17.1 ± 2.4) and BF% (18.0 ± 5.2 vs. 19.4 ± 5.0). Children engaged in more sedentary, light, moderate, and vigorous physical activity and had higher counts per minute during weekdays compared to weekend days. There were no sex differences in moderate to vigorous physical activity (87.6 ± 22.4 vs. 93.5 ± 20.6 min and 53.6 ± 21.3 vs. 59.4 ± 22.0 min) during weekday and weekend days. Data indicated that 96% of the girls and 92% of the boys met the international physical activity guideline for children of 60 minutes of MVPA, on weekdays.     

Antigenic activity and the reactogenicity of a concentrated, purified, UV-inactivated cultured rabies vaccine

The results of the study of concentrated, purified, UV-inactivated cell-culture rabies vaccine, obtained from strain Vnukovo-22, passage 33-40, in the primary culture of Syrian hamster kidney cells, demonstrated the pronounced antigenic potency of this vaccine: when introduced intramuscularly in 3-4 injections at certain intervals, it induced the production of virus-neutralizing antibodies in high titers. In tests on volunteers the vaccine proved to be nonreactogenic.     

Optimal inoculation doses of meningococcal chemical polyvalent ABC vaccine for immunizing children of various ages and adolescents. I. Safety and reactogenicity of different dosages of the preparation

The investigation was carried out to study the safety and reactogenicity of meningococcal chemical polyvalent (ABC) vaccine with the aim of finding the optimum vaccination doses of this vaccine for the immunization of children of different age groups. The investigation, carried out in accordance with the methodological principles of a strictly controlled epidemiological field trial, showed the preparation to be safe, nonreactogenic and to produce no pronounced sensitizing effect.     

Correlation of group C meningococcal conjugate vaccine response with B- and T-lymphocyte activity

Despite the success of conjugate vaccination against meningococcal group C (MenC) disease, post-vaccination, some individuals still exhibit rapid waning of initially protective bactericidal antibody levels. The mechanism of this relative loss of humoral protection remains undetermined. In this report we have investigated the relationship between T- and B-cell activation and co-stimulation and the loss of protective antibody titers. We have found that healthy volunteers who lose protective MenC antibody levels one year after receipt of glycoconjugate vaccine exhibit no detectable cellular defect in polyclonal B- or T-cell activation, proliferation or the B-memory pool. This suggests that the processes underlying the more rapid loss of antibody levels are independent of defects in either initial T- or B-cell activation.     

2～59岁健康人群接种ACYW135群脑膜炎球菌多糖疫苗的免疫原性观察

目的评价ACYW135群脑膜炎球菌多糖疫苗在2～59岁健康人群中的免疫原性。方法 2～59岁健康人群接种者随机抽样(n=60),接种一剂四价脑膜炎球菌多糖疫苗。采集接种前和接种后1个月血清,采用体外杀菌试验(Serum bactericidal assay,SBA)检测血清中抗A、C、Y、W135群脑膜炎球菌的血清杀菌滴度。结果免疫前、后血清抗A群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为1241(736,2091)和7559(5520,10351)(P<0.05);抗C群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为4(9,21)和4787(2947,7775)(P<0.05);抗W135群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为16(9,28)和368(162,883)(P<0.05);抗Y群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为120(58,246)和1373(687,2745)(P<0.05)。免疫前和免疫后血清抗A群脑膜炎球菌的杀菌滴度≥128的比例分别为87(77.4,95.1)%和100(83.2,100)%;抗C群脑膜炎球菌的比例分别为17(8.3,28.5)%和97(88.5,99.6)%;抗W135群脑膜炎球菌的比例分别为13(5.9,24.6)%和68(55.0,79.7)%;抗Y群脑膜炎球菌的比例分别为57(43.2,69.4)%和85(73.4,92.9)%。免疫后较免疫前抗A群、C群、W135群和Y群脑膜炎球菌杀菌抗体滴度≥4倍升高的比例分别为50(27.2,72.8)%、97(88.5,99.6)%、62(43.2,73.9)%和55(41.6,67.9)%。结论虽然免疫前人群由于地方和国家免疫计划的实施已具有较高水平的抗A群脑膜炎球菌的血清杀菌滴度,但接种ACYW135群脑膜炎球菌多糖疫苗后可以使其保护水平进一步提高,并使人群对C群、W135群和Y群脑膜炎球菌的低水平杀菌抗体滴度均显著升高达到保护水平,证明ACYW135群脑膜炎球菌多糖疫苗在2～59岁健康人群中具有比较好的免疫原性。     

The characteristics of the reactogenicity and immunological activity of a new cholera bivalent chemical vaccine based on the results of controlled trials]

The reactogenic properties and immunological potency of modified cholera chemical vaccine (choleragen-toxoid + O-antigens Inaba and Ogawa) were tested in 278 volunteers aged 18 years and over in comparison with those of a commercial batch of monovalent cholera vaccine (choleragen-toxoid + O-antigen Inaba). The cholera vaccine, enriched with O-antigen Ogawa, was found to be safe; vaccination with this vaccine was not accompanied by the development of systemic and local reactions whose frequency and intensity met the requirements for the reactogenic properties of commercial cholera vaccine. The immunological potency of the bivalent vaccine with respect to strain Inaba was not inferior to that of the commercial vaccine; at the same time in persons immunized with the new preparation the titers of vibriocidal antibodies to strain of serovar Inaba were five-fold higher. The conclusion on the expediency of using cholera chemical vaccine enriched with O-antigen Ogawa was made.