Phase 4
N=219
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
Chronic Obstructive Pulmonary Disease · Asthma · Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT02787863 ↗Enrolled (actual)
219
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. — 3; 5; 1; 0 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prevenar-13 (Biological); Pneumo-23 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mikhael Petrovich Kostinov
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. |
3; 5; 1; 0; 3; 1 | <0.05 sig |
| PRIMARY The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation |
1.97; 2.24; 2.13; 2.68; 2.22; 2.39 | <0.05 sig |
| SECONDARY Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD |
21; 12; 18; 10; 18; 5 | — |
| SECONDARY Average CAT (COPD) and ACQ-5 (Asthma) Score |
21.8; 1.8; 22.8; 2; 16.8; 1.1 | — |
| SECONDARY Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination |
65; 63; 71; 65; 84; 64.3 | — |
| SECONDARY Immunophenotype of Blood Lymphocytes in Patients With COPD |
67.3; 69.6; 69.7; 69.9; 69; 71.3 | — |
| SECONDARY IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) |
3.57; 3.33; 3.74; 3.39; 3.79; 3.52 | — |
| SECONDARY CD45RO |
0.1; 0.1; 0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes |
69.7; 66.9; 87.5; 88; 132.7; 106.9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02787863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.