RESUMEN
In the controlled trial carried out among children aged 1-4 years, the safety, reactogenicity and immunological potency of group A meningococcal polysaccharide vaccine produced at the Gabrichevskii Research Institute of Epidemiology and Microbiology (Moscow) were studied. The vaccine under test was introduced in two doses containing 15 and 25 micrograms of meningococcal polysaccharide. Both doses were shown to be safe, faintly reactogenic and immunologically potent. Systemic reactions were manifested by a transient rise in temperature to subfebrile levels in 19% and to 37.8-38.2 degrees C in 4.7% of the vaccinees. The temperature dropped to the normal level by the end of the first day following vaccination. At the site of injection skin hyperemia up to 2-3 cm in diameter was registered in 74% and up to 5-6 cm in diameter, in 6% of the vaccinees. Hyperemia disappeared on day 2 after vaccination. The production of antibodies to group A meningococcal polysaccharide occurred in response to both doses under test, and the elevated antibody level (in comparison to the initial one) was retained perceptibly longer in response to a dose of 25 micrograms; this dose, considering its low reactogenicity, was chosen as the optimal dose for children of the above age group.
Asunto(s)
Vacunas Bacterianas/efectos adversos , Neisseria meningitidis/inmunología , Polisacáridos Bacterianos/inmunología , Anticuerpos Antibacterianos/análisis , Vacunas Bacterianas/inmunología , Preescolar , Ensayos Clínicos como Asunto , Relación Dosis-Respuesta Inmunológica , Pruebas de Hemaglutinación , Humanos , Lactante , Factores de Tiempo , Vacunación/métodos , Vacunas Sintéticas/efectos adversos , Vacunas Sintéticas/inmunologíaAsunto(s)
Meningitis Neumocócica/diagnóstico , Factores de Edad , Niño , Preescolar , Humanos , Lactante , Recién Nacido , Meningitis Neumocócica/terapiaAsunto(s)
Meningitis Neumocócica/diagnóstico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antibacterianos/uso terapéutico , Niño , Preescolar , Quimioterapia Combinada , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Meningitis Neumocócica/tratamiento farmacológico , Meningitis Neumocócica/etiología , Meningitis Neumocócica/mortalidad , Persona de Mediana Edad , Serotipificación , Streptococcus pneumoniae/clasificación , Factores de TiempoRESUMEN
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.
Asunto(s)
Vacunas Bacterianas/inmunología , Neisseria meningitidis/inmunología , Polisacáridos Bacterianos/inmunología , Adolescente , Envejecimiento/efectos de los fármacos , Vacunas Bacterianas/administración & dosificación , Vacunas Bacterianas/efectos adversos , Temperatura Corporal/efectos de los fármacos , Niño , Preescolar , Relación Dosis-Respuesta Inmunológica , Evaluación de Medicamentos , Humanos , Factores de TiempoAsunto(s)
Toxoide Diftérico/efectos adversos , Vacuna contra la Tos Ferina/efectos adversos , Convulsiones/inducido químicamente , Toxoide Tetánico/efectos adversos , Adsorción , Animales , Sistema Nervioso Central/efectos de los fármacos , Preescolar , Combinación de Medicamentos , Electroencefalografía , Humanos , Lactante , Ratones , Síndrome , Factores de Tiempo , Ácido gamma-Aminobutírico/biosíntesisRESUMEN
To detect meningococcal antigen, the use of the enzyme-labeled immunosorbent assay (ELISA), a new variant of the immunoenzymatic method, permitting one to carry out quantitative analysis, is proposed. The optimum conditions for the test to detect group A meningococcal antigen, as well as the procedure for the approbation of the test on patients with meningococcal infection and on healthy persons, have been worked out. The method is shown to be highly specific and sensitive.