title: [SAFETY AND IMMUNOGENICITY OF A NATIONAL COMBINED VACCINE AGAINST PERTUSSIS, DIPHTHERIA, TETANUS, HEPATITIS B AND Hib-INFECTION, CONTAINING ACELLULAR PERTUSSIS COMPONENT, DURING IMMUNIZATION OF ADULTS].
abstract: OBJECTIVE
  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.
  
  
  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:
  
  
  CONCLUSIONS
  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.
authors.forename: I V
authors.initials: IV
authors.lastname: Feldblyum
authors.forename: A M
authors.initials: AM
authors.lastname: Nikolaeva
authors.forename: K A
authors.initials: KA
authors.lastname: Pavroz
authors.forename: T V
authors.initials: TV
authors.lastname: Danilina
authors.forename: O Yu
authors.initials: OY
authors.lastname: Sosnina
authors.forename: T V
authors.initials: TV
authors.lastname: Vyaznikova
authors.forename: A E
authors.initials: AE
authors.lastname: Ershov
authors.forename: D M
authors.initials: DM
authors.lastname: Trofimov
authors.forename: A V
authors.initials: AV
authors.lastname: Polushkina
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis* / Q000097:blood; D000914:Antibodies, Viral / Q000096:biosynthesis* / Q000097:blood; D004165:Diphtheria / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology; D006801:Humans; D056724:Immunity, Humoral / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D013742:Tetanus / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D014611:Vaccination; D022223:Vaccines, Subunit; D014917:Whooping Cough / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D022223:Vaccines, Subunit