Safety and immunogenicity of the CIGB 2020.

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.

Scientific title:

CIGB 2020 Phase I / II Clinical Trial to assess safety and immunogenicity of different routes and modes of administration in older adults. Randomized parallel group clinical trial.

Secondary indentifying numbers:

IG/VPNSL/IRA/2002

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, 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:

Alina

Last name:

Diaz Machado

Medical Specialty :

1st Degree Specialist in Pharmacology

Affiliation:

National Toxicology Center (CENATOX)

Postal address:

Calle 114 y Ave. 31, Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-72743265

Email address:

alydm@infomed.sld.cu [1]

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:

Not applicable

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

29/07/2020

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

Health condition(s) code:

Immunosenescence

Aging

Growth and Development

Immunocompetence

Immune System Phenomena

Intervention(s):

Group 1-Control: CIGB 2020 by nasal route (spray: 0.1 mL in each nostril, in 5 cycles with 5-minute intervals) at baseline (time 0), at 7 and 14 days, and by sublingual route, daily, for 14 days. Group 2-Experimental: CIGB 2020 by nasal route (1 mL drops) at baseline (time 0), at 7 and 14 days, and sublingually, daily, for 14 days. Group 3-Experimental: CIGB 2020 by nasal route (1 mL in drops) at baseline (time 0), at 7 and 14 days. Group 4-Experimental: CIGB 2020 sublingually (1 mL), daily, for 14 days.

Intervention code:

Immunotherapy, Active

Administration, Sublingual

Administration, Intranasal

Intervention keyword:

CIGB 2020 vaccine

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):

Activation of markers of the innate immune system (levels of TLR3, TLR7, or TLR8): Measurement time: at baseline and, on day 15 (end of treatment).

Key secondary outcomes:

1. Percentage of patients with increased expression of TLR3; TLR7; TLR8. Measurement time: at baseline and on days 8 and 15 post-treatment. 2. Clinical Adverse Events-AE (They will be measured as: -AE occurrence (Yes, No), -AE description (name of event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event)). Measurement time: daily throughout the follow-up of the subjects.

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- Age greater than or equal to 60 years, both sexes. 2- Personal history of HT, DM, cardiovascular diseases, kidney disease, cancer, osteoarthritis, atherosclerosis, obesity, chronic inflammatory disorders, autoimmune disorders, or any other that could constitute a risk factor for the competition of your innate immune system. 3- Expression levels of at least one of the Toll-like receptors: TLR3, TLR7 and TLR8, lower than the GUS control. 4- Voluntary nature of the patient to participate expressed through the delivery of signed informed consent.

Exclusion criteria:

1- Expression levels of each of the Toll-like receptors (TLR3, TLR7 and TLR8), all above the GUS control. 2- Diagnosis of SARS-CoV-2 infection within 14 days prior to recruitment. 3- Acute illness at the time of recruitment, defined as the presence of a moderate or severe illness with or without fever. 4- Axillary temperature ≥ 38.0 ° C. 5- History of tonsillectomy. 6- Use of immunosuppressive drugs or chemotherapy at some point during the month prior to recruitment. 7- Use of any investigational product (medicine or vaccine) within 30 days prior to recruitment, or that has been planned during the study period. 8- Liver cirrhosis, hepatocellular carcinoma or a history of liver transplantation. 9- History of allergy to any of the ingredients of the vaccine under study. 10- Any problem that makes proper patient monitoring impossible.

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:

Other

Other purpose:

Early stage prevention or treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Doctor in medicine. 1st degree specialist in Clinical Biochemistry.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, +53-72087465

Email :

zurina.cinza@cigb.edu.cu [2]

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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Doctor in medicine. 1st degree specialist in Clinical Biochemistry.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, +53-72087465

Email :

zurina.cinza@cigb.edu.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

National Toxicology Center (CENATOX)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/06/2020

Postal address of Ethic Committee :

Calle 114 y Ave. 31, Marianao, Havana. Cuba. PB 11500

Telephone:

+53-72743265

Correo electrónico:

alydm@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

15/09/2020

Date of available results:

15/10/2020

Date of first publication:

15/12/2020

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:

RPCEC00000326

Date of Registration in Primary Registry:

14/07/2020

Record Verification Date:

2020/10/21

Next update date:

2021/10/21

Link to the spanish version:

Click here [3]