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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 : Completed
First Posted : June 1, 2016
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: 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 6, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD with Prevenar-13 (1)
33 patients with COPD. Standard therapy with Prevenar-13.
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Experimental: Asthma with Prevenar 13 (2)
34 patients with asthma. Standard therapy with Prevenar 13.
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Experimental: COPD with Pneumo-23 (3)
25 patients with COPD. Standard therapy with Pneumo-23.
Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23

Experimental: Asthma with Pneumo-23 (4)
25 patients with asthma. Standard therapy with Pneumo-23.
Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23

Experimental: COPD with Pneumo-23/Prevenar-13 (5)
32 patients with COPD. Standard therapy, vaccinated with pneumococcal polysaccharide vaccine/pneumococcal conjugate vaccine (PPV23/PCV13).
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23

Experimental: Asthma with Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23

Experimental: COPD with Prevenar-13/Pneumo-23 (7)
25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23

Experimental: Asthma with Prevenar-13/Pneumo-23 (8)
27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.
Biological: Prevenar-13
Conjugate 13 serotype pneumococcal vaccine
Other Name: PCV13

Biological: Pneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Other Name: PPV23




Primary Outcome Measures :
  1. Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. [ Time Frame: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination ]
    Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.

  2. The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation [ Time Frame: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination ]
    The number of exacerbations of the underlying disease, antibiotic use and hospitalisation. The average number of exacerbations per 1 patient = total exacerbations in the group / number of patients in the group. This is not a mean value.


Secondary Outcome Measures :
  1. Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD [ Time Frame: Baseline, after 1 and 4 years after vaccination ]
    Seeding frequency S. pneumoniae from sputum in patients with COPD

  2. Average CAT (COPD) and ACQ-5 (Asthma) Score [ Time Frame: Baseline, after 1 and 4 years after vaccination ]

    CAT - COPD Assessment Test, min. = 0, max. = 40, higher scores mean a worse outcome.

    ACQ-5 - Asthma control questionnaire, min. = 0, max. = 6, higher scores mean a worse outcome.


  3. Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination [ Time Frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination ]

    Phagocytic index (granulocytes), phagocytic index (monocytes), activity of a spontaneous HCT test (neutrophils), activity of an induced HCT test (neutrophils), percentage of HCT-positive white blood cells in a spontaneous test. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100 (phagocytic index)

    The phagocytic index was calculated by counting at least 100 bacteria phagocytized by certain number of phagocytic cells/macrophages and expressed following formula (Mamnur Rashid 1997):

    Phagocytic index = Total no. of phagocytized bacteria /No of phagocytic cells phagocytizing bacteria.

    Activation index = % formazan positive cells (FPC) in NBT stimulated / % formazan positive cells (FPC) in NBT Spontaneous.


  4. Immunophenotype of Blood Lymphocytes in Patients With COPD [ Time Frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination ]
    Immunophenotype of blood lymphocytes in patients with COPD at baseline, 1, 2 and 6 weeks after PCV13 and PPV23 vaccination. It was pre-specified to report data from only the "COPD - Prevenar-13" and the "COPD - Pneumo-23" Arms/Groups for this Outcome Measure". This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).

  5. IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) [ Time Frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD ]
    IgA, IgM, IgG, IgE, circulating immune complexes (CIC) in serum at baseline, 1, 2 and 6 weeks after vaccination. It was pre-specified to report data from only the "COPD - Prevenar-13" and the "COPD - Pneumo-23" Arms/Groups for this Outcome Measure". This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).

  6. CD45RO [ Time Frame: Baseline, 1 and 4 years after vaccination ]
    CD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups.

  7. Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes [ Time Frame: Baseline, 1 and 12 months after vaccination ]
    Mean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination



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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 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.

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


Locations
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Russian Federation
Samara State Medical Univercity
Samara, Samara Region, Russian Federation, 443099
Institute of Sera and Vaccines RAS
Moscow, Russian Federation, 105064
Sponsors and Collaborators
Mikhael Petrovich Kostinov
Pfizer
Investigators
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Principal Investigator: Andrei D Protasov, Professor Samara State Medical University
Principal Investigator: Mikhael P Kostinov, Professor Institute of Sera and Vaccines RAS, Moscow
Study Chair: Mikhael P Kostinov, Professor Institute of Sera and Vaccines RAS, Moscow
Study Chair: Aleksander V Zhestkov, Professor Samara State Medical University
Publications of Results:
Protasov AD, Zhestkov AV, Kostinov MP. First results of 13-valent pneumococcal conjugate vaccine treatment in patients with chronic bronchopulmonary diseases: evaluation safety and tolerability. Russian Allergology Journal 4: 18-23, 2013.
Protasov AD.COMPARATIVE EVALUATION OF THE EFFECTIVENESS OF PNEUMOCOCCAL VACCINATION WITH 13-VALENT CONJUGATE AND 23-VALENT POLYSACCHARIDE VACCINE IN PATIENTS WITH COPD. Russian Allergology 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
Protasov AD, Zhestkov AV, Kostinov MP, Korymasov EA, Shteyner ML, Tezikov YV, Lipatov IS, Reshetnikova VP, Lavrent'yeva NE. Long-term clinical efficacy and a possible mechanism of action of different modes of pneumococcal vaccination in asthma patients. Pulmonology 28(2): 193-199, 2018.

Other Publications:
Protasov AD. Pneumococcal vaccination in patients with chronic broncho-pulmonary disease (literature review). The Bulletin of Contemporary Clinical Medicine. 6(2): 60-65, 2013.

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Responsible Party: Mikhael Petrovich Kostinov, MD, PhD, Chief of Laboratory of Vaccines and Allergotherapy of allergic diseases, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02787863    
Other Study ID Numbers: 115030370013
First Posted: June 1, 2016    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mikhael Petrovich Kostinov, Russian Academy of Medical Sciences:
Pneumococcal vaccines
Additional relevant MeSH terms:
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Pneumococcal Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs