Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
CIMAvax-EGF® vaccine group (experimental): One dose (2.4 mg) of the vaccine will be administered intramuscularly in an induction phase and a maintenance phase. In the induction phase, one dose will be
Sponsors
Center for Molecular Immunology
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for COPD according to GOLD (FEV1/FVC value < 0.7) 2. Patients of either sex and age greater than or equal to 18 years. 3. Patients who have signed the informed consent for the research (Annex 2). 4. Patients who meet the diagnostic criteria, whose disease is moderate or severe according to GOLD criteria (Moderate: FEV1 less than 80%, greater than or equal to 50% of the predicted value; Severe: FEV1 less than 50%, greater than or equal to 30% of the predicted value). 5. Patients whose symptoms are controlled with the use of standard pharmacological treatment. 6. Patients of childbearing age who agree to use adequate contraceptive methods (for example, hormonal or barrier contraceptive methods, abstinence) before entering the study. If a woman becomes pregnant or suspects she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or postpartum patients. 2. Patients with uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia. 3. Patients with mild to very severe COPD. 4. Patients with psychiatric illness or social situations that would limit compliance with study requirements. 5. Patients who have received another investigational product within 30 days prior to enrollment. 6. Patients with known immunosuppressive disease (e.g., HIV, AIDS, or other immunosuppressive disease). Testing is not mandatory. 7. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to CIMAvax-EGF® or other agents used in the study. 8. Patients with any active and concurrent malignant disease except non-melanoma skin cancer and carcinoma in situ of the cervix. There must be no current evidence of activity of prior malignant disease. 9. Patients with bronchial asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of occurrence of clinically important deterioration events (ICD) (Occurrence of at least 1 of the following events: 1) decrease = 100 mL with respect to baseline FEV 1, 2) increase = 4 units in SGQR with respect to baseline, occurrence of moderate or severe exacerbation event) Time of measurement: Month 6 and month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavior of pulmonary function (by spirometry). Time of measurement: At baseline, month 6 and month 12. Quality of life (To be assessed using the health-related quality of life survey (SGQRQ) and the COPD Impact on Quality of Life Assessment Questionnaire). Time of measurement: At baseline, month 6 and month 12. | — |
Countries
Cuba
Contacts
Public ContactLorena Requeiro Rodriguez
Center of Molecular Immunology
Outcome results
None listed