Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 520
• Participant gender: Both

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, proinflammatory cytokines, inflammatory markers in patients in the dynamics of the vaccination process. Study the profile of humoral immune response in patients under different schemes of vaccination. Detection of levels of autoantibodies against tissue antigens in the sera of vaccinated patients with inflammatory diseases of the respiratory tract. Assessment of the clinic and functional status bronchopulmonary system in the immunized patients. Development of methodical recommendations / study guides for the improvement of therapy in patients with different inflammation diseases of the respiratory tract.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mikhael Petrovich Kostinov
• Collaborator: Pfizer
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Vaccines
• Last Updated: 2016-06-03

Criteria

Inclusion Criteria:

• Individuals of both sexes from 18 years with a diagnosis of community-acquired pneumonia, 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:

• community-acquired pneumonia: the presence of radiologically confirmed infiltration of the lung tissue; the presence of at least two of the following clinical signs: acute fever early in the disease (temperature > 38.0°C), cough with sputum, the physical signs of pneumonia (focus of crepitate and/or fine bubble rales, bronchial breathing hard, shortening of percussion sounds), leukocytosis > 10*10 9 /l and/or stab shift > 10%; the occurrence of the disease outside the hospital and the organized groups (such as nursing homes, sanatoriums, etc.).

• 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 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 of 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.