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

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ClinicalTrials.gov Identifier: NCT02787863
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mikhael Petrovich Kostinov, Russian Academy of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Asthma Pneumococcal Infections Biological: Prevenar 13 Biological: Immunovac Drug: Polioxidonium Biological: Pneumo-23 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathogenetic Justification and Clinical and Immunological Efficiency of Application Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
Actual Study Start Date : September 2012
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD with immunovac VP4
35 patients with COPD will receive Immunovac VP4 on a combined scheme route + parenterally in combination with a base of antibacterial and symptomatic therapy
Biological: Immunovac
Vaccine against Staphylococcus aureus, Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli.
Other Name: VP4

Experimental: Asthma with immunovac VP4
35 patients with asthma, will receive Immunovac VP4 on a combined scheme route + parenterally in combination with basic and symptomatic therapy
Biological: Immunovac
Vaccine against Staphylococcus aureus, Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli.
Other Name: VP4

No Intervention: Asthma and COPD without vaccines
Patients with COPD and bronchial asthma: standard therapy without the use of vaccine preparation.
Experimental: C-a pneumonia with Immunovac VP4 per os
35 patients with community-acquired pneumonia will receive Immunovac VP4 on a combined scheme route + oral in combination with basic antibacterial and symptomatic therapy
Biological: Immunovac
Vaccine against Staphylococcus aureus, Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli.
Other Name: VP4

Experimental: C-a pneumonia with Immunovac VP4 p/e
35 patients with community-acquired pneumonia will receive Immunovac VP4 on a combined scheme route + parenterally in combination with a base of antibacterial and symptomatic therapy
Biological: Immunovac
Vaccine against Staphylococcus aureus, Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli.
Other Name: VP4

No Intervention: C-a pneumonia without Immunovac VP4
35 patients with community-acquired pneumonia will be therapy without the use of vaccine preparation.
Experimental: COPD with Polioxidonium
35 patients with COPD. Standard and antibacterial therapy with Polioxidonium.
Drug: Polioxidonium
Polioxidonium. Immunomodulatory drug. Increases the body's resistance against local and generalized infections. The basis of the mechanism of immunomodulating effect of Polyoxidonium is a direct impact on faguoqitirute cells and natural killer cells, and stimulation of antibody production. Active ingredient: anoxemia bromide (polyoxidonium).

No Intervention: COPD without Polioxidonium
35 patients with COPD. Standard and antibacterial therapy without Polioxidonium.
Experimental: COPD with Prevenar-13
30 patients with COPD. Standard therapy with Prevenar-13.
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Experimental: Asthma with Prevenar 13
30 patients with asthma. Standard therapy with Prevenar 13.
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Experimental: COPD with Pneumo-23
30 patients with COPD. Standard therapy with Pneumo-23
Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.

Experimental: Asthma with Pneumo-23
30 patients with asthma. Standard therapy with Pneumo-23
Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.

Experimental: COPD with Prevenar 13 & Pneumo-23
30 patients with COPD. Standard therapy, vaccinated with Prevenar 13 and after with Pneumo-23
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.

Experimental: Asthma with Prevenar 13 & Pneumo-23
30 patients with Asthma. Standard therapy, vaccinated with Prevenar 13 and after with Pneumo-23
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.

Experimental: COPD with Pneumo-23 and Prevenar 13
30 patients with COPD. Standard therapy, vaccinated with Pneumo-23 and after with Prevenar 13
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.

Experimental: Asthma with Pneumo-23 and Prevenar 13.
30 patients with Asthma. Standard therapy, vaccinated with Pneumo-23 and after with Prevenar 13
Biological: Prevenar 13
Conjugate 13 serotype pneumococcal vaccine

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.




Primary Outcome Measures :
  1. The number of exacerbations of the underlying disease. [ Time Frame: 2 year ]
    The number of exacerbations of the underlying disease, revealed more and using laboratory methods.


Secondary Outcome Measures :
  1. The incidence of upper respiratory tract infections. [ Time Frame: 1 year ]
    The number of cases of acute respiratory infections in the last year, identified anamnestic method.

  2. The incidence of upper respiratory tract infections. [ Time Frame: 2 уеаr ]
    The number of cases of acute respiratory infections in the last year, identified anamnestic method.

  3. The incidence of upper respiratory tract infections. [ Time Frame: 3 year ]
    The number of cases of acute respiratory infections in the last year, identified anamnestic method.

  4. The number of exacerbations of the underlying disease. [ Time Frame: 1 year ]
    The number of exacerbations of the underlying disease, revealed more and using laboratory methods.

  5. The number of exacerbations of the underlying disease. [ Time Frame: 3 year ]
    The number of exacerbations of the underlying disease, revealed more and using laboratory methods.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787863


Contacts
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Contact: Mikhael P Kostinov, M.D., Ph.D +7-495-917-41-49 vaccinums@gmail.com
Contact: Andrey D Protasov, Ph.D. +7-927-744-41-26 crosss82@mail.ru

Locations
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Russian Federation
Samara State Medical Univercity Completed
Samara, Samara Region, Russian Federation, 443099
Institute of Sera and Vaccines RAS Recruiting
Moscow, Russian Federation, 105064
Contact: Elena S Korovkina, Ph.D.    +79167176115    elen208@yandex.ru   
Contact: Mikhael P Kostinov, M.D., Ph.D.    +79637823523    vaccinums@gmail.com   
Sub-Investigator: Alexander G Tchuchalin, M.D., Ph.D.         
Sub-Investigator: Svetlana V Kazharova         
Sponsors and Collaborators
Mikhael Petrovich Kostinov
Pfizer
Investigators
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Principal Investigator: Mikhael P Kostinov, M.D., Ph.D. Institute of Sera and Vaccines RAS, Moscow
Study Director: Mikhael P Kostinov, M.D., Ph.D. Institute of Sera and Vaccines RAS, Moscow
Study Chair: Mikhael P Kostinov, M.D., Ph.D. Institute of Sera and Vaccines RAS, Moscow

Publications of Results:
Protasov AD, Zhestkov AV, Kostinov MP. The first results of the use of 13-valent conjugated pneumococcal vaccine in patients with chronic broncho-pulmonary pathology: evaluation of safety and tolerability. Russian Allergological Journal 4: 18-23, 2013
Protasov AD.Comparative evaluation of the effectiveness of vaccination against pneumococcal infection in patients with chronic obstructive pulmonary disease with the use of 13-valent conjugate and 23-valent polysaccharide vaccine. Russian Allergological Journal 4: 12-17, 2014
Kostinov MP, Protasov AD, Zhestkov AV, Polishuk VB. Promising data with pneumococcal 13-valent conjugate vaccine in adult patients with chronic bronchopulmonary pathology. Pulmonology 4: 57-63, 2014
Protasov AD. Comparative evaluation of the effectiveness of vaccination against pneumococcal infection in patients with bronchial asthma with the use of 13-valent conjugate and 23-valent polysaccharide vaccine. Pulmonology. 5: 52-56, 2014
Kostinov MP, Zhestkov AV, Protasov AD, Kostinova TA, Pakhomov DV, Chebykina AV, Magarshak OO.Comparative analysis of dynamics of indicators of quality of life in patients with chronic obstructive pulmonary disease on the background of vaccination against pneumococcal disease using the 13-valent conjugate and 23-valent polysaccharide vaccine. Pulmonology 25(2): 163-166, 2015

Other Publications:
Protasov AD. Vaccination against pneumococcal infection in patients with chronic bronchopulmonary pathology (review of literature). Herald of modern clinical medicine. 6(2): 60-65, 2013

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Responsible Party: Mikhael Petrovich Kostinov, MD, PhD, Shef of Laboratory of Vaccines and Allergotherapy of allergic diseases, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02787863     History of Changes
Other Study ID Numbers: 115030370013
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mikhael Petrovich Kostinov, Russian Academy of Medical Sciences:
Pneumococcal vaccine
Polioxidonium
Additional relevant MeSH terms:
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Pneumococcal Infections
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs