Evaluation of the synergistic effect of sequential administration of two immunostimulant products: Immuno-1 and Immuno-2 for the stimulation of the immune response in older adults. Exploratory study

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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:

InmunoCorona

Scientific title:

Evaluation of the synergistic effect of sequential administration of two immunostimulant products: Immuno-1 and Immuno-2 for the stimulation of the immune response in older adults. Exploratory study (COVID-19)

Acronym of Scientific Title:

InmunoCorona

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Finlay Vaccine Institute (IFV), National Center for Biopreparations (BioCen)

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)

Authorization date :

18/05/2020

Reference number:

In process

Principal investigator

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

First name:

Rinaldo

Last name:

Puga Gomez

Medical Specialty :

Medical doctor. Specialist of second degree in Pediatric. Diploma of Immunology (1988).

Affiliation:

Clinica Central Cira Garcia

Postal address:

Calle 20 No. 4101 esq. a Av. 41, Miramar, Playa

City:

La Habana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72042811

+53-59961340

Email address:

puga@infomed.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:

Havana, Clinic 1.Medical Services, Leslyhana Verdecia Sanchez, MD, Internal medicine specialist

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

19/05/2020

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:

Immunosenescence in the elderly and their susceptibility to infectious diseases.

Intervention(s):

Inmuno-1: Injectable, intramuscularly. Contents 3 mg of Inmuno-1 in 3 mL of volume. Inmuno-2: Injectable, intramuscularly. Contents 50 ug of Inmuno-2, in 3 mL of volume. Group I (Experimental) – Inmuno-1 + Inmuno-2: Three doses of Inmuno-1 on alternate days + single dose of Inmuno-2 at seven days after the first dose of Inmuno-1. Group II (Control) - Inmuno-2: Single dose of Inmuno-2 Group III (Control) – Inmuno-1: Three doses of Inmuno-1on alternate days

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):

Lymphocytes T CD3+CD4+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Lymphocytes T CD3+CD8+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Lymphocytes B CD19+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. NK cells CD3-CD56+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Monocyte cells CD14+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Dendritic cells CD11c+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.

Key secondary outcomes:

Clinical Adverse Events-AE (They will be measured as: -AE Occurrence (Yes, No), -AE Description (name of the event), -Location: (local or systemic), Time of appearance: (Immediate, Delayed), Knowledge Previous: (Expected or not expected), AEs intensity (mild, moderate, severe), - Consequence (Serious, not serious), Causal relationship (very probable, probable, possible, improbable, unrelated, not evaluable/not classifiable), Outcome (recovered, not recovered, recovered with sequelae, death due to AD or unknown), - Attitude towards treatment (Continuation, definitive discontinuation)). Measurement time: up to 7 days after the end of the treatment

Selection criterias

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

Gender:

Male/Female

Minimum age:

60 years

Maximum age:

None

Inclusion criteria:

1.- Female or male subject, age ≥ 60 years. 2.- Written consent to participate in the study. 3.- Negative result to the rapid antibody test against COVID-19.

Exclusion criteria:

1.- Subject with a history of acute infectious disease at the time of application of the research products or in the 7 days prior to the administration of the same 2.- Subject with a history of acute allergic processes or a history of severe allergic reactions. 3.- Subject with a history of chronic decompensation diseases 4.- Subjects with known hypersensitivity to any of the components of the research products 5.- Subjects with immunomodulatory treatment (immunostimulatory or immunosuppressive) 6.- Immunocompromised or immunosuppressed subjects (eg HIV, autoimmune disease) 7.- Subjects who received the research products three months before the start of the research

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

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

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

60

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:

Rinaldo

Last Name:

Puga Gomez

Specialty:

Medical doctor. Specialist of second degree in Pediatric. Diploma of Immunology (1988).

Affiliation:

Clinica Central Cira Garcia

Postal Address:

Calle 20 No. 4101 esq. a Av. 41, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72042811

Email :

puga@infomed.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:

Dagmar

Last Name:

Garcia Rivera

Specialty:

PhD. Pharmaceutical Sciences

Affiliation:

Finlay Vaccine Institute

Postal Address:

Ave 198, No. 19810, entre 198 y 200 Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72080984

Email :

dagarcia@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Hematology and Immunology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/04/2020

Postal address of Ethic Committee :

Calle 19 entre 8 y 10, Vedado, Plaza, Havana, Cuba.

Telephone:

+53-78461152

Email:

vmarsan@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/06/2020

Date of available results:

30/07/2020

Date of first publication:

01/09/2020

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:

RPCEC00000315

Date of Registration in Primary Registry:

22/05/2020

Record Verification Date:

2020/05/22

Next update date:

2021/05/22

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Evaluation of the synergistic effect of sequential administration of two immunostimulant products: Immuno-1 and Immuno-2 for the stimulation of the immune response in older adults. Exploratory study

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