Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
Condition: Chronic Obstructive Pulmonary Disease; Asthma; Pneumococcal Infections
MeSH terms: Pneumococcal Infections; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Prevenar-13; Pneumo-23
Intervention description: Conjugate 13 serotype pneumococcal vaccine; Polysaccharide 23-valent pneumococcal vaccine.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccines

Summary:

      Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic
      effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary
      system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper
      respiratory tract in patients with bronchopulmonary pathology before and after use of
      bacterial vaccines. Identification of mayor lymphocytes subpopulations in patients in the
      dynamics of the vaccination process. Study the profile of humoral immune response in patients
      under different schemes of vaccination. Assessment of the clinic and functional status
      bronchopulmonary system in the immunized patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals of both sexes from 18 years with a diagnosis of COPD or Bronchial Asthma;

          -  The presence of signed and dated informed consent to participate in a clinical study;

          -  The ability to perform the requirements of the Protocol;

          -  For women of childbearing age is a negative result of a pregnancy test before
             vaccination.

        Diagnostic criteria for:

        - COPD: dyspnea: progressive (worsens over time), increases with exertion, persistent;
        chronic cough (may appear sporadically and may be unproductive); chronic expectoration; the
        impact of risk factors in the medical history (Smoking, occupational dust pollutants and
        chemicals); widespread wheeze on auscultation of the chest and/or distant wheezing in the
        chest; family history of COPD; spirometric data confirming the presence of fixed bronchial
        obstruction.

        Exclusion Criteria:

          -  Vaccination against pneumococcal infection in anamnesis;

          -  Application of preparations of immune globulin or blood transfusion within last three
             months prior to clinical studies;

          -  Prolonged use (more than 14 days) immunosuppressants or other immunosuppressive drugs
             within 6 months prior to the start of the study;

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             Human Immunodeficiency Virus (HIV) infection;

          -  A history or currently hematologic and other cancers;

          -  A positive reaction for HIV infection, viral hepatitis B and hepatitis C;

          -  The presence of respiratory, cardio-vascular insufficiency, impaired liver and kidney
             function, established during a physical examination at visit number 1;

          -  Pronounced congenital defects or serious chronic diseases in the acute stage,
             including any clinically important exacerbation of chronic diseases of the liver,
             kidney, cardiovascular, nervous system, mental diseases or metabolic disorders,
             confirmed by the history or objective examination (pulmonary: cystic fibrosis, lung
             abscess, empyema, active tuberculosis; extra-pulmonary: congestive heart failure,
             malabsorption, chronic renal and hepatic failure, cirrhosis, malignancy,
             immunodeficiency, cirrhosis of the liver);

          -  Severe allergic reactions in anamnesis, autoimmune disease;

          -  The presence of acute infectious and/or communicable illnesses within 1 month prior to
             study;

          -  History of chronic alcohol abuse and/or drug use;

          -  Exacerbation of chronic diseases;

          -  Breastfeeding;

          -  Pregnancy;

          -  Participation in any other clinical study within the last 3 months.