RESUMO
AIM: Study safety, reactogenicity and immunologic effectiveness of a national combined vaccine against diphtheria, pertussis (acellular component), tetanus, hepatitis B and Hib-infection during immunization of volunteers aged 18-60 years. MATERIALS AND METHODS: The study was carried out in accordance with ethical standards and requirements, regulated by Helsinki declaration and Good clinical practice (ICHGCP). In a simple non-randomized clinical trial 20 adult volunteers took part, the mean age of those was 46.9 years. RESULTS: Registered: post-vaccination reactions (both local and systemic) were mild and of moderate degree of severity, stopped independently after 2-3 days without administration of drug treatment. Postvaccinal complications were not noted. Parameters of general and biochemical analysis of blood, urine, IgE content in dynamics of immunization were within normal limits. A single administration of aAPDT--HepB+Hib to individuals aged 18-60 years resulted in development of antibodies against all the components of the preparation. Seroconversion factor fluctuated from 6.9 to 53.5: CONCLUSION: The results obtained allow to recommend the vaccine for evaluation of its safety, reactogenicity, immunologic and prophylaxis effectiveness in randomized clinical observation trials in children.
Assuntos
Anticorpos Antibacterianos/biossíntese , Anticorpos Antivirais/biossíntese , Difteria/prevenção & controle , Infecções por Haemophilus/prevenção & controle , Hepatite B/prevenção & controle , Tétano/prevenção & controle , Coqueluche/prevenção & controle , Adolescente , Adulto , Anticorpos Antibacterianos/sangue , Anticorpos Antivirais/sangue , Difteria/imunologia , Difteria/microbiologia , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/química , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Feminino , Infecções por Haemophilus/imunologia , Infecções por Haemophilus/microbiologia , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas Anti-Haemophilus/química , Vacinas Anti-Haemophilus/imunologia , Hepatite B/imunologia , Hepatite B/virologia , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/química , Vacinas contra Hepatite B/imunologia , Humanos , Imunidade Humoral/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Tétano/imunologia , Tétano/microbiologia , Vacinação , Vacinas de Subunidades Antigênicas , Coqueluche/imunologia , Coqueluche/microbiologiaRESUMO
AIM: Justification of the use of immune chromatographic analysis for diagnostic of pneumococcal pneumonia. MATERIALS AND METHODS: Sensitivity and specificity of an immune chromatographic method (Binax Now test system) was studied for verification of pneumococcal pneumonia. Approbation of this method for etiologic deciphering of pneumonia in 260 patients hospitalized in infectious hospital was carried out. RESULTS: A high sensitivity (84.8%) and specificity (90.5%) of the chromatography test was established. Streptococcus pneumoniae antigen in urine of patients with community acquired pneumonia was determined 3.6 times more frequently when immune chromatographic test was used compared with bacteriological study of nasopharyngeal swab and 1.8 times more frequently compared with sputum bacteriological study. CONCLUSION: Application of immune chromatographic express test Binax Now could be recommended for timely verification of pneumococcal pneumonia along with bacteriological methods of study.