Revisions for SOBERANA 02-FaseIII | Registro Público Cubano de Ensayos Clínicos

--- 30 October 2021 - 12:03pm by FINLAY
+++ 23 June 2022 - 4:19pm by FINLAY
+-03-03 00:00:00
-Pending
+Complete
-No
+Yes
--03-05 00:00:00
+-03-08 00:00:00
+The protocol  and other supporting clinical documents, including statistical analysis plan,  informed consent and  the interim and final reports will be available after publication in specialized journals.
+Any additional interest should be be sent to: mariaeugenia@ipk.sld.cu  or vicente.verez@finlay.edu.cu.
+These proposals must be reviewed and approved by the sponsor and investigator. Finally, data access agreement must be signed.
+https://www.finlay.edu.cu/blog/category/sala-cientifica/

SOBERANA 02-FaseIII

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 02-FaseIII

Scientific title:

Phase III clinical trial, multicenter, adaptive, parallel-group, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and immunogenicity of vaccination against SARS-CoV-2 with 2 doses of FINLAY-FR-2 and a heterologous scheme with 2 doses of FINLAY-FR-2 and a booster dose with FINLAY-FR-1A (COVID-19)

Acronym of Scientific Title:

SOBERANA 02-Fase III

Secondary indentifying numbers:

IFV/COR/09

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) from Ministry of Science, Technology and Enviroment

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 :

03/03/2021

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 in Integral General Medicine. Doctor of Medical Science

Affiliation:

Instituto de Medicina Tropical “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:

Havana, Plaza municipality, Policlinic Plaza, Lisi Munniz, MD. Specialist in Integral General Medicine.

Havana, Plaza municipality, Policlinic Moncada, Ingrid Rodriguez Crespo, MD. Specialist in Integral General Medicine.

Havana, Plaza municipality, Policlinic Vedado, Centro Atencion al Diabético, Liz Caballero, MD. Specialist in Integral General Medicine.

Havana, Plaza municipality, Policlinic 19 de Abril, Susel Perez, MD. Specialist in Integral General Medicine.

Havana, Playa municipality, Policlinic 5 de septiembre, Amaury Miranda, MD. Specialist in Integral General Medicine.

Havana, Playa municipality, Policlinic Manuel Fajardo, Yanislaydy Cabriales, MD. Specialist in Integral General Medicine.

Havana, Playa municipality, Policlinic 26 de Julio, Aylin Molina, MD. Specialist in Integral General Medicine.

Havana, Centro Habana municipality, Policlinic Marcio Manduley, Rudrany Rodriguez, MD. Specialist in Integral General Medicine.

Havana, Centro Habana municipality, Policlinic Docente Reina, Marlene Sosa, MD. Specialist in Integral General Medicine.

Havana, Centro Habana municipality, Escuela de Musica Amadeu Roldan, Maura Suarez, MD. Specialist in Integral General Medicine.

Havana, Centro Habana municipality, Casona China, Marlene Sosa, MD. Specialist in Integral General Medicine.

Havana, La Lisa municipality, Policlinic Elpidio Berovides, Carlos Perez, MD. Specialist in Integral General Medicine.

Havana, La Lisa municipality, Policlinic Cristobal Labra, Luis Vivas, MD. Specialist in Integral General Medicine.

Havana, La Lisa municipality, Policlinic Antonio Pulido, Lena Martinez, MD. Specialist in Integral General Medicine.

Havana, Habana Vieja municipality, Policlinic Aballi, Jose Miguel Perez, MD. Specialist in Integral General Medicine.

Havana, Habana Vieja municipality, Policlinic Romay, Yuneisy Cantero, MD. Specialist in Integral General Medicine.

Havana, Habana Vieja municipality, Policlinic Zulueta, Yalilka Obama, MD. Specialist in Integral General Medicine.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

08/03/2021

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

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Experimental Group 1: FINLAY-FR-2 25 µg RBD-TT, Intramuscular (IM), 0.5 mL, 0 – 28 days. Presentation: Vial with single dose. Experimental Group 2: FINLAY-FR-2 25 µg RBD-TT, IM, 0.5 mL, 0 – 28 days + FINLAY-FR-1A (50 µg d-RBD+ alumina, IM, 0.5 mL) as booster dose 56 days. Presentation: Vial with single dose. Placebo Group: IM, 0.5 mL, 0 – 28 days. Presentation: Vial with single dose.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

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):

Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation.

Key secondary outcomes:

1. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 2. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 3. Death from causes directly attributable to a complication of COVID-19 Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 4. Virologically confirmed disease of Covid-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 5. Duration of the disease, measured from: Time to negativization and Duration of symptoms 6. Immunogenicity (IgG antibody concentration, Neutralizing antibody titre, determined by neutralization assay and ACE2-RBD interaction inhibition assay (% inhibition at 1/100 dilution; ID50). Measurement time: from 14 days after the candidate's first dose and until the end of the study (approximately 160 days) 7. Reactogenicity (Incidence of Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from onset date until end date of event), Time of onset (Time from the previous dose to the onset of AE), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), - Causal relationship (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: 3 days after each dose 8. Safety Incidence of Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from onset date until end date of event), Time of onset (Time from the previous dose to the onset of AE), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality relationship (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: 28 days after each dose

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

Exclusion criteria:

1. Subjects with acute febrile or infectious disease in the 7 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 hypersensitivity to thiomersal or to some of the components of the formulation. 4. Previous or current history of SARS-CoV-2 infection (questioning) 5. Application of vaccines containing tetanus toxoid in the last 3 months. 6. Subjects previously vaccinated against SARS-CoV-2. 7. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, Biomodulin T, any gamma globulin, Levamisole, Heberferon, 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. 8. Pregnancy, puerperium or lactation. 9. Subjects with tattoos in the deltoid region on both arms. 10. Decompensated chronic diseases that limit vaccination according to clinical criteria. 11. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 12. Subjects with unstabilized malignant disease or who are receiving cytostatic treatment and / or radiotherapy during the time of the study or have been receiving it in the last three months.

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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

44010

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:

Mayra

Last Name:

Garcia Carmenate

Specialty:

Master of Science. 1st Degree Specialist in Comprehensive General Medicine. Assistant teacher. Head of the Department of Trasmisible Diseases

Affiliation:

Provincial Center of Hygiene and Epidemiology of Havana

Postal Address:

Av. 31 y 100. Marianao.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-772600713

Email :

mayragc@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:

Meiby

Middle Name:

de la Caridad

Last Name:

Rodriguez Gonzalez

Specialty:

1st degree Specialist Physician in General Medicine. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute

Postal Address:

St 21 and 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-772718331

Email :

mcrodriguez@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Research Ethics Committee Centralized Extended

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

02/03/2021

Postal address of Ethic Committee :

Manuel Fajardo Faculty of Medical Sciences. 29 and C, Vedado, Plaza de la Revolucion. Havana. Cuba

Telephone:

+53-53602191

Email:

About study completion

Section to complete the data related to the study completion.

Study completion date:

07/11/2021

Date of available results:

15/01/2022

Date of first publication:

30/01/2022

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:

RPCEC00000354

Date of Registration in Primary Registry:

03/03/2021

Record Verification Date:

2021/10/30

Next update date:

2022/10/30

Link to the spanish version:

Click here

Registered Trials

Registration process

SOBERANA 02-FaseIII

About the RPCEC

Useful resources