CIMAvax®-EGF in patients with moderate-severe chronic obstructive pulmonary disease (COPD)

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

COPD-VAX

Scientific title:

Safety and efficacy of CIMAvax-EGF® in patients with moderate-severe chronic obstructive pulmonary disease (COPD) compared to usual pharmacological treatment in the controlled phase of the disease. Phase II/III controlled clinical trial

Acronym of Scientific Title:

COPD-VAX

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Molecular Immunology, Ministry of Public Health of Cuba

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Pedro

Midle name:

Pablo

Last name:

Pino Alfonso

Medical Specialty :

Second Degree Specialist in Pulmonology

Affiliation:

“Hermanos Ameijeiras” Surgical Clinical Hospital

Postal address:

San Lazaro # 701 esq. a Belascoain

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-5378761436

Email address:

broncoscopia@hha.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Holguin, "Vladimir Ilich Lenin" General Teaching Hospital, Irmary Riveron Proenza, MD. Second degree specialist in Neumology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

07/04/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic obstructive pulmonary disease (COPD)

Intervention(s):

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 administered every 14 days until 4 doses are completed. In the maintenance phase, one dose will be administered every 28 days, until the appearance of unmanageable toxicity or the worsening of the patient's general condition. CIMAvax-EGF® will be administered in conjunction with the best available supportive care, which includes the use of inhaled bronchodilators of the beta-agonist type, antimuscarinics, inhaled corticosteroids, and contraphylline or similar administered orally, at the doses and duration established in the protocol, in monotherapy, dual therapy or triple therapy according to current standards (GOLD 2023) for the stable state of the disease, as decided by the specialist responsible for the treatment of the patients. Control group: It will receive the best available maintenance treatment equal to the experimental group.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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:

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

212

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Lorena

Last Name:

Requeiro Rodriguez

Specialty:

Medical Doctor

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 esquina a 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+53-72717933 ext 3489

Email :

lorena@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Lorena

Last Name:

Requeiro Rodriguez

Specialty:

Medical Doctor

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 esquina a 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+53-72717933 ext3489

Email :

lorena@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Hermanos Ameijeiras” Surgical Clinical Hospital

"Vladimir Ilich Lenin" General Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/10/2023

19/09/2023

Postal address of Ethic Committee :

San Lazaro # 701 esq. a Belascoain, Centro Habana, ZC:10400, Havana, Cuba

Lenin No. 2, entre 18 y 26, Rpto. Lenin, ZC: 80100, Holguin. Cuba

Telephone:

+53-7876 1019

+53-24461601

Correo electrónico:

direccion@hha.sld.cu

jesusfg@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

05/07/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000457

Date of Registration in Primary Registry:

24/03/2025

Record Verification Date:

2025/03/24

Next update date:

2026/03/24

Link to the spanish version:

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CIMAvax®-EGF in patients with moderate-severe chronic obstructive pulmonary disease (COPD)

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