Revisions for SOBERANA 01 | Registro Público Cubano de Ensayos Clínicos

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Revision of 12 October 2020 - 5:48pm:

SOBERANA 01

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 01

Scientific title:

Phase I / II, randomized, controlled, adaptive, double-blind and multicenter study to evaluate the safety, reactogenicity and immunogenicity, of the prophylactic FINLAY-FR-1 anti-SARS-CoV-2 Vaccine Candidate in a two-doses schedule. (COVID-19)

Acronym of Scientific Title:

SOBERANA 01

Secondary indentifying numbers:

IFV/COR/04

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 :

13/08/2020

Reference number:

05.009.20BA

Principal investigator

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

First name:

Sonia

Last name:

Perez Rodriguez

Medical Specialty :

First degree specialist in Internal Medicine

Affiliation:

National Toxicology Center (CENATOX)

Postal address:

Avenue. 31 and 114 street. Marianao

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72603252

+53-72601230

+53-72608751

Email address:

cenatox@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:

Polyclinic "April 19", Mayra Garcia Carmenate, MD. First degree specialist in Comprehensive General Medicine

Clinic 1 La Lisa, Leslyhana Verdecia Sanchez, First degree specialist in Internal Medicine

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

24/08/2020

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:

Prevention of COVID-19 disease

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19, SARS-CoV-2

Intervention(s):

FINLAY-FR-1 intervention (Experimental): Dose 10 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. FINLAY-FR-1 intervention (Experimental): Dose 20 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. VA-MENGOC-BC® intervention (Control): Dose of 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. In each intervention will be two age groups: 19-59 years and 60-80 years.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Single Dose

Meningococcal Vaccines

Intervention keyword:

VA-MENGOC-BC®

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) 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) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time At baseline and, 14, 28 and, 56 days.

Key secondary outcomes:

1) Solicited Local and systemic Adverse Events measured as: -Occurrence of the Adverse Event (Yes, No), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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 7 days after each dose. 2) Unsolicited Adverse Events measured as: Description of the Adverse Event (name of the event), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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 3) Neutralizing antibody titer, measurement time: At baseline and, 56 days.

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 written informed consent to participate in the study. 2. Subjects aged between 19-59 and 60-80 years. 3. Body mass index between 18 and 29.9 kg / m2. 4. Women of childbearing potential using safe contraceptive methods during the study. 5. General, regional and apparatus physical examination: normal or without clinically significant alterations. 6. Clinical Laboratory testing within the range of reference values, or outside but not clinically significant (Only for Phase I)

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 treated with antimicrobials or NSAIDs in the 7 days prior to the administration of the vaccine. 3. Subjects with non-trasmisible chronic diseases not controlled according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, psychiatric disease at a psychotic level) . 4. Subjects with congenital or acquired immune system disease. 5. Subjects with a history of unresolved neoplastic disease. 6. Subjects with a personal history of liver or kidney failure. 7. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except withdrawal. 8. Subjects with diminished mental faculties. 9. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 10. Subjects with a history of hypersensitivity to thiomersal or other component of the formulation. 11. Subjects with a history of SARS and COVID-19 who meet any of the following criteria: a) Previous or current history of SARS-CoV 2 infection. b) Be declared in the category of contact or suspect at the time of inclusion c) Subject with positive rapid test for SARS-CoV 2. d) Patient with a positive PCR at the time of inclusion. 12. Participation in another clinical trial in the last 3 months. 13. Application of another vaccine in the last 30 days. 14. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any gammaglobulin, Levamisole, Heberferon, thymosin) or predictably those people that due to their underlying disease could require immunomodulatory treatment during the study. 15. Transfusion of blood or blood products in the last 3 months for phase I and last 30 days for phase II. 16. Patients with difficulties in attending planned follow-up visits. 17. Splenectomy or splenic dysfunction. 18. 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 controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

676

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 bw/ 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:

Rodríguez Gonzalez

Specialty:

Ffirst degree specialist in Comprehensive General Medicine. Master in Epidemiology

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 avenue bw/ 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:

National Toxicology Center (CENATOX)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

07/08/2020

Postal address of Ethic Committee :

Ave. 31 and 114 street. Apdo. 14020 Marianao. Havana. Cuba

Telephone:

+53-72603252

Email:

cenatox@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

40

Study completion date:

11/01/2021

Date of available results:

01/02/2021

Date of first publication:

15/02/2021

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:

RPCEC00000332

Date of Registration in Primary Registry:

13/08/2020

Record Verification Date:

2020/09/08

Next update date:

2021/09/08

Link to the spanish version:

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