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

NCT02787863 | Completed Phase 4 Results

• 1 other identifier: 115030370013
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma; Pneumococcal Infections

Keywords

Pneumococcal vaccines

Outcome Measures

Primary Outcomes (2)

• Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.

  Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.

  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 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.

  Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination

Secondary Outcomes (7)

• Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD

  Baseline, after 1 and 4 years after vaccination

• Average CAT (COPD) and ACQ-5 (Asthma) Score

  Baseline, after 1 and 4 years after vaccination

• Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination

  Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination

• Immunophenotype of Blood Lymphocytes in Patients With COPD

  Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination

• IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)

  Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD

Study Arms (8)

COPD with Prevenar-13 (1)

EXPERIMENTAL

33 patients with COPD. Standard therapy with Prevenar-13.

Biological: Prevenar-13

Asthma with Prevenar 13 (2)

EXPERIMENTAL

34 patients with asthma. Standard therapy with Prevenar 13.

Biological: Prevenar-13

COPD with Pneumo-23 (3)

EXPERIMENTAL

25 patients with COPD. Standard therapy with Pneumo-23.

Biological: Pneumo-23

Asthma with Pneumo-23 (4)

EXPERIMENTAL

25 patients with asthma. Standard therapy with Pneumo-23.

Biological: Pneumo-23

COPD with Pneumo-23/Prevenar-13 (5)

EXPERIMENTAL

32 patients with COPD. Standard therapy, vaccinated with pneumococcal polysaccharide vaccine/pneumococcal conjugate vaccine (PPV23/PCV13).

Biological: Prevenar-13; Biological: Pneumo-23

Asthma with Pneumo-23/Prevenar-13 (6)

EXPERIMENTAL

18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.

Biological: Prevenar-13; Biological: Pneumo-23

COPD with Prevenar-13/Pneumo-23 (7)

EXPERIMENTAL

25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.

Biological: Prevenar-13; Biological: Pneumo-23

Asthma with Prevenar-13/Pneumo-23 (8)

EXPERIMENTAL

27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.

Biological: Prevenar-13; Biological: Pneumo-23

Interventions

Prevenar-13 BIOLOGICAL

Conjugate 13 serotype pneumococcal vaccine

Also known as: PCV13

Asthma with Pneumo-23/Prevenar-13 (6); Asthma with Prevenar 13 (2); Asthma with Prevenar-13/Pneumo-23 (8); COPD with Pneumo-23/Prevenar-13 (5); COPD with Prevenar-13 (1); COPD with Prevenar-13/Pneumo-23 (7)

Pneumo-23 BIOLOGICAL

Polysaccharide 23-valent pneumococcal vaccine.

Also known as: PPV23

Asthma with Pneumo-23 (4); Asthma with Pneumo-23/Prevenar-13 (6); Asthma with Prevenar-13/Pneumo-23 (8); COPD with Pneumo-23 (3); COPD with Pneumo-23/Prevenar-13 (5); COPD with Prevenar-13/Pneumo-23 (7)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mikhael Petrovich Kostinov: lead
• Pfizer: collaborator

Study Sites (2)

Samara State Medical Univercity

Samara, Samara Oblast, 443099, Russia

Location

Institute of Sera and Vaccines RAS

Moscow, 105064, Russia

Location

Related Publications (9)

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

  BACKGROUND

• 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.

  RESULT

• 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.

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• Protasov AD, Kostinov MP, Zhestkov AV, Shteiner ML, Magarshak OO, Kostinova TA, Ryzhov AA, Pakhomov DV, Blagovidov DA, Panina MI. [Choice of optimal vaccination tactics against pneumococcal infection from immunological and clinical standpoints in patients with chronic obstructive pulmonary disease]. Ter Arkh. 2016;88(5):62-69. doi: 10.17116/terarkh201688562-69. Russian.

  PMID: 27239929 RESULT

• Protasov AD, Zhestkov AV, Kostinov MP, Shteiner ML, Tezikov YV, Lipatov IS, Yastrebova NE, Kostinova AM, Ryzhov AA, Polishchuk VB. [Analysis of the effectiveness and long-term results of formation of adaptive immunity in the use of various medications and vaccination schemes against pneumococcal infection in patients with chronic obstructive pulmonary disease]. Ter Arkh. 2017;89(12. Vyp. 2):165-174. doi: 10.17116/terarkh20178912165-174. Russian.

  PMID: 29488477 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine; 23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Professor Andrei Dmitrievich Protasov, Professor Mikhail Petrovich Kostinov
• Organization: Samara State Medical University, Institute of Sera and Vaccines RAS

crosss82@mail.ru

+79277444126

Study Officials

• Andrei D Protasov, Professor

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

• Mikhael P Kostinov, Professor

  Institute of Sera and Vaccines RAS, Moscow

  PRINCIPAL INVESTIGATOR

• Mikhael P Kostinov, Professor

  Institute of Sera and Vaccines RAS, Moscow

  STUDY CHAIR

• Aleksander V Zhestkov, Professor

  Samara State Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Chief of Laboratory of Vaccines and Allergotherapy of allergic diseases

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 1, 2016
• Study Start: September 6, 2012
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)