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

NCT02787863

Last updated date
Study Location
Institute of Sera and Vaccines RAS
Moscow, , 105064, Russian Federation
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease, Asthma, Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Chronic Obstructive Pulmonary Disease, Asthma, Pneumococcal InfectionsClinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
NCT02787863
  1. Moscow,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
Official Title  ICMJE Pathogenetic Justification and Clinical and Immunological Efficiency of Application Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
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.
Detailed Description

Methods:

  1. Immunoglobulin G (IgG)-antibodies against Streptococcus pneumoniae (S. pneumoniae) - solid-phase enzyme-linked immunoelectrodiffusion essay (ELISA).
  2. General levels of Immunoglobulin A (IgA), Immunoglobulin M (IgM), IgG, Immunoglobulin E (IgE) in sera - radial immunodiffusion.
  3. Phagocytic activity (granulocytes, monocytes), nitroblue tetrazolium test; T-lymphocytes, T-helpers (cluster of differentiation, CD3+CD4+), cytotoxic T-lymphocytes (?D3+CD8+), B-lymphocytes (CD19+); NK-cells (CD3-CD16+CD56+), NKT-cells (CD3+CD16+CD56+), activated T-cells (human leucocyte antigens, CD3+HLA DR+), CD3-HLA DR+.
  4. Microbiological examination of sputum.
  5. Determining the clinical effectiveness of vaccination.

    • the number of exacerbations of chronic bronchopulmonary pathology for the year prior to vaccination and during the first and fourth years after vaccination;
    • the number of courses of antibiotic therapy a year prior to vaccination and during the first and fourth years after immunization;
    • the number of hospitalizations for acute exacerbations of chronic bronchopulmonary disease during the year prior to vaccination and during the first and fourth years after immunization.
  6. Method of estimating quality of life associated with health in patients with chronic bronchopulmonary pathology (asthma control questionnaire (ACQ-5), COPD assessment test (CAT)).

Characteristics of variables (arms 1-8).

  1. The age of patients (years): mean (standard deviation) [min; median; max] for normally distributed variables; median [Q25; Q75] - for variables with distribution different from normal.
  2. Gender: male/female.
  3. Indicators of immune status

    • IgG antibodies to S. pneumoniae
    • IgA, g/l [0,4-3,5]
    • IgM, g/l [0,7-2,8]
    • IgG, g/l [8-18]
    • IgE, IU/ml [< 100]
    • Phagocytic index (granulocyte), % [82-90]
    • Phagocytic index (monocytes), % [75-85]
    • The participation rate of spontaneous NBT-test (neutrophils), % with intensity of 0.2.e. [7-14]
    • The index of activity induced NBT-test (neutrophils), % if intensity >of 0.36.e. [>28]
    • The percentage of NBT-positive cells in spontaneous test, % [2-19]
    • Circulating immune complexes (CEC) cond. units [0,055-0,11]
    • CD3+, % [55-80]
    • CD3+CD4+, % [31-49]
    • CD3+CD8+, % [12-30]
    • CD19+, % [5-19]
    • CD3-CD16+CD56+, % [6-20]
    • CD3+CD16+CD56+, % [<10]
    • CD3-HLA DR+, % [5-20]
    • CD3+HLA DR+, % [<12]
    • CD45RO. The reference value = 0,2.
  4. Microbiological examination of sputum: frequency of selection of certain microorganisms are presented as absolute number of cases and % in the respective groups.
  5. Evaluation of early post-vaccination period

    • The General condition (satisfactory/unsatisfactory)
    • Local reactions: pain (n/%), redness (n/%, cm), consolidation (n/%, cm)
    • General reactions:

      • Temperature 37,0-37,5 (n/%)
      • Temperature of 37.6-38,5 (n/%)
      • A temperature of 38.6 and > (n/%)
      • Headache (n/%)
      • Malaise, fatigue (n/%)
      • Joint pain (n/%)
      • Muscle pain (n/%)
  6. Health related quality of life (HRQoL): CAT-test (for Chronic obstructive pulmonary disease (COPD) patients), ACQ-5 (for asthma patients).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Asthma
  • Pneumococcal Infections
Intervention  ICMJE
  • Biological: Prevenar-13
    Conjugate 13 serotype pneumococcal vaccine
    Other Name: PCV13
  • Biological: Pneumo-23
    Polysaccharide 23-valent pneumococcal vaccine.
    Other Name: PPV23
Study Arms  ICMJE
  • Experimental: COPD with Prevenar-13 (1)
    33 patients with COPD. Standard therapy with Prevenar-13.
    Intervention: Biological: Prevenar-13
  • Experimental: Asthma with Prevenar 13 (2)
    34 patients with asthma. Standard therapy with Prevenar 13.
    Intervention: Biological: Prevenar-13
  • Experimental: COPD with Pneumo-23 (3)
    25 patients with COPD. Standard therapy with Pneumo-23.
    Intervention: Biological: Pneumo-23
  • Experimental: Asthma with Pneumo-23 (4)
    25 patients with asthma. Standard therapy with Pneumo-23.
    Intervention: Biological: Pneumo-23
  • Experimental: COPD with Pneumo-23/Prevenar-13 (5)
    32 patients with COPD. Standard therapy, vaccinated with pneumococcal polysaccharide vaccine/pneumococcal conjugate vaccine (PPV23/PCV13).
    Interventions:
    • Biological: Prevenar-13
    • Biological: Pneumo-23
  • Experimental: Asthma with Pneumo-23/Prevenar-13 (6)
    18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.
    Interventions:
    • Biological: Prevenar-13
    • Biological: Pneumo-23
  • Experimental: COPD with Prevenar-13/Pneumo-23 (7)
    25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.
    Interventions:
    • Biological: Prevenar-13
    • Biological: Pneumo-23
  • Experimental: Asthma with Prevenar-13/Pneumo-23 (8)
    27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.
    Interventions:
    • Biological: Prevenar-13
    • Biological: Pneumo-23
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2020)
219
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2016)
520
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787863
Other Study ID Numbers  ICMJE 115030370013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Mikhael Petrovich Kostinov, Russian Academy of Medical Sciences
Study Sponsor  ICMJE Mikhael Petrovich Kostinov
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Andrei D Protasov, ProfessorSamara State Medical University
Principal Investigator:Mikhael P Kostinov, ProfessorInstitute of Sera and Vaccines RAS, Moscow
Study Chair:Mikhael P Kostinov, ProfessorInstitute of Sera and Vaccines RAS, Moscow
Study Chair:Aleksander V Zhestkov, ProfessorSamara State Medical University
PRS Account Russian Academy of Medical Sciences
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP