Revisions for SOBERANA CENTRO | Registro Público Cubano de Ensayos Clínicos

Current revision:

SOBERANA CENTRO

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:

SOBERANA CENTRO

Scientific title:

Phase II randomized, double-blind, parallel-group, adaptive and multicenter study to evaluate the non-inferiority of the immune response in adults of the prophylactic anti-SARS-CoV-2 vaccine candidate FINLAY-FR-1 compared to FINLAY-FR-02 in Heterologous Two Dose and One Boost Dose Schedules with FINLAY-FR-1A. (COVID-19)

Acronym of Scientific Title:

SOBERANA CENTRO

Secondary indentifying numbers:

IFV/COR/14

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (IFV)

Source(s) of monetary or material support:

Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) of Ministry of Science, Technology and Enviroment (CITMA)

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:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

First Degree Specialist Physician in Integral General Medicine. Doctor of Medical Science

Affiliation:

Institute of Tropical Medicine "Pedro Kouri"

Postal address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email address:

mariaeugenia@ipk.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:

Cienfuegos, Palmira. Manuel Piti Fajardo Polyclinic. Laydami Cardenas Gonzalez, MD. First Degree Specialist in Integral General Medicine

Cienfuegos, Cruces. Manuel Piti Fajardo Polyclinic. Belkys Elena Morales Hernandez, MD. First Degree Specialist in Integral General Medicine

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

26/07/2021

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:

COVID-19

Health condition(s) code:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Healthy Volunteers

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group 1 (experimental) FINLAY-FR-1: 50 µg RBD + 20 µg EMV / alumina; 0.5 mL, Intramuscular (IM), 0-28 days + Booster dose day 56 FINLAY-FR-1A: 50 µg dRBD / alumina, 0.5 mL, Intramuscular (IM). Presentation: Vial with single dose. Group 2 (experimental) FINLAY-FR-2: 25 µg of RBD-TT / alumina; 0.5 mL, Intramuscular (IM), 0-28 days + Booster dose day 56 FINLAY-FR-1A: 50 µg dRBD / alumina, 0.5 mL, Intramuscular (IM). Presentation: Vial with single dose.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Intervention keyword:

SOBERANA

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):

Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70. Moreover, in a subset of subjects’ samples with seroconversion, the outcome will measure at months 4, 8 and 12 after completing scheme vaccination.

Key secondary outcomes:

1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose. 2) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose. 3) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose. 4) % ACE2-RBD inhibition: Measurement time: Day 42 and 70 (It is measured on the total of subjects’ samples with seroconversion). 5) Molecular neutralization titer. Measurement time: Day 42 and 70 (It is measured on the total of subjects’ samples with seroconversion). 6) Neutralizing antibody titer: Measurement time Day 42 and 70 (It is measured on a subset of samples).

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:

80 years

Inclusion criteria:

1) Subjects aged between 19 and 80 years. 2) Subjects who give their informed consent to participate in the study in writing. 3) Women of childbearing age who use contraceptive methods during the study and are willing to use them up to three months after the corresponding vaccination schedule has concluded.

Exclusion criteria:

1) Subjects with acute febrile or infectious disease in the seven days prior to the administration of the vaccine or at the time of its application. 2) Subjects with diminished mental faculties for decision making. 3) Subjects with a history of known hypersensitivity to any of the components of the formulation. 4) Previous history of SARS-CoV-2 infection or subjects positive to the antigen test at the time of inclusion. 5) Subjects previously vaccinated against SARS-CoV-2. 6) Application of vaccines containing tetanus toxoid or the VA-MENGOC-BC vaccine in the last three months. 7) Application of any other vaccine of the extended immunization schedule in the last 30 days. 8) Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, HeberFERON, immunoferon, transfer factor, biomodulin T, any gamma globulin, levamisole, thymosin or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study. 9) Subjects with tattoos in the deltoid region on both arms. 10) Decompensated chronic diseases that limit vaccination according to criteria clinical. 11) Subjects with unstabilized malignant disease or who are receiving oncospecific treatment (cytostatics and / or radiotherapy) during the time of the study or have been receiving it in the last three months. 12) HIV positive subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 13) Pregnancy, puerperium or lactation.

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 trial

Masking:

Double Blind

Control group:

Uncontrolled

Study design:

Parallel

Phase:

2

Target sample size:

1166

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:

Beatriz

Last Name:

Paredes Moreno

Specialty:

Pharmaceutical Sciences

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 avenue between 198 and 200 Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72718331

Email :

bparedes@finlay.edu.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:

Meiby

Middle Name:

de la Caridad

Last Name:

Rodriguez Gonzalez

Specialty:

First Degree Specialist in Integral General Medicine. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 avenue between 198 and 200 Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72718331

Email :

mcrodriguez@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

University of Medical Sciences, Cienfuegos

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/07/2021

Postal address of Ethic Committee :

Calle 51 A y Ave. 5 de Septiembre. Municipio Cienfuegos. Provincia Cienfuegos, Cuba

Telephone:

+53-55189034

Email:

rectora-ucmcfg@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/09/2022

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:

RPCEC00000385

Date of Registration in Primary Registry:

23/07/2021

Record Verification Date:

2021/08/09

Next update date:

2022/08/09

Link to the spanish version:

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19 December 2022 - 11:15am by FINLAY		8 January 2026 - 5:55am by Gladys
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