Revisiones para SOBERANA - INTERVENTION | Registro Público Cubano de Ensayos Clínicos

--- 19 Marzo 2021 - 3:00pm por Gladys
+++ 9 Noviembre 2021 - 2:44pm por FINLAY
 . Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time:  from 14 days after the candidate's last dose.
 . Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose.
 . Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose.
+. Evaluate the immunogenicity of a dose of the vaccine candidate, in convalescent patients from COVID-19 with mild and moderate clinical symptoms and asymptomatic PCR positive.
 . Death from causes directly attributable to a complication of COVID-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days.
 . 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.
 . Proportion of hospitalized subjects. Measurement time: from 14 days after the candidate's first dose.
+. Evaluate the duration of the immune response in primed subjects.
+. Evaluate the capacity to reinforce the immune response of SOBERANA 01 and SOBERANA Plus, after administration of the planned heterologous scheme, between 5-6 months after the last dose.
+. Evaluate the duration of the immune response induced by both booster doses for a minimum period of 6 months.
 Experimental Group: FINLAY-FR-2 25 µg RBD-TT, Intramuscular route (IM), 0.5 mL, 0 – 28 days + FINLAY-FR-1A (50 µg d-RBD+ alumina, IM, 0.5 mL) as booster dose 56 day.
 FINLAY-FR-2 Presentation: Vial with single dose and vial multidoses
 FINLAY-FR-1A Presentation: Vial with single dose and vial multidoses
+Finlay -FR- 1Presentation:  Vial with single dose and vial multidoses
 . Pregnancy, childbirth and the puerperium.
 . Acute illness that contraindicates vaccination
 . HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.
+. For the application of the booster dose, subject with a history of being convalescent of COVID, or having less than 5 months of the last dose applied.
-/03/19
+/11/09
-/03/19
+/11/09

SOBERANA - INTERVENTION

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 - INTERVENTION

Scientific title:

INTERVENTIONAL TRIAL TO EVALUATE DIRECT AND INDIRECT EFFECTS OF VACCINATION ANTI SARS COV 2 IN POPULATION COHORT AT RISK OF INFECTION, DISEASE AND DISPERSION OF THE EPIDEMIC (COVID-19)

Acronym of Scientific Title:

SOBERANA - INTERVENTION

Secondary indentifying numbers:

IFV/COR/10

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)

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

País:

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, Provincial Health Direction of Havana, Mayra Garcia Carmenate, 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:

Pending

Date of first enrollment:

22/03/2021

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: FINLAY-FR-2 25 µg RBD-TT, Intramuscular route (IM), 0.5 mL, 0 – 28 days + FINLAY-FR-1A (50 µg d-RBD+ alumina, IM, 0.5 mL) as booster dose 56 day. FINLAY-FR-2 Presentation: Vial with single dose and vial multidoses FINLAY-FR-1A Presentation: Vial with single dose and vial multidoses Finlay -FR- 1Presentation: Vial with single dose and vial multidoses

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):

1. Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the candidate's last dose. 2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the candidate's last dose. 3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the candidate's last dose. 4. Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose. 5. Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose. 6. Evaluate the immunogenicity of a dose of the vaccine candidate, in convalescent patients from COVID-19 with mild and moderate clinical symptoms and asymptomatic PCR positive.

Key secondary outcomes:

1. Virologically confirmed disease of Covid-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 4. Death from causes directly attributable to a complication of COVID-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 5. 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. 6. Proportion of hospitalized subjects. Measurement time: from 14 days after the candidate's first dose. 8. Evaluate the duration of the immune response in primed subjects. 9. Evaluate the capacity to reinforce the immune response of SOBERANA 01 and SOBERANA Plus, after administration of the planned heterologous scheme, between 5-6 months after the last dose. 10. Evaluate the duration of the immune response induced by both booster doses for a minimum period of 6 months.

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. Both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate

Exclusion criteria:

1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection as a result of medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunomodulators in the 30 days prior to vaccination. 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, childbirth and the puerperium. 7. Acute illness that contraindicates vaccination 8. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 9. For the application of the booster dose, subject with a history of being convalescent of COVID, or having less than 5 months of the last dose applied.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

150000 for the stage in risk group.

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

País:

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

País:

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 Ad hoc

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

17/03/2021

Postal address of Ethic Committee :

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

Telephone:

+53-53602191

Correo electrónico:

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/08/2022

Date of available results:

31/10/2022

Date of first publication:

29/12/2022

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:

RPCEC00000360

Date of Registration in Primary Registry:

19/03/2021

Record Verification Date:

2021/11/09

Next update date:

2022/11/09

Link to the spanish version:

Click here

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SOBERANA - INTERVENTION

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