Revisions for SOBERANA 01B | Registro Público Cubano de Ensayos Clínicos

--- 13 February 2021 - 9:52am by FINLAY
+++ 27 April 2021 - 4:58pm by FINLAY
+-12-30 00:00:00
-In process
+/05-017-20BA
-Pending
+Complete
-No
+Yes
+The immunological individual data, and other supporting clinical documents, including study protocol, statistical analysis plan, and the informed consent form will be available after publication in specialized journals. Proposals should be sent to: ochoa@finlay.edu.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.
+The Study protocol, statistical analysis plan, and the informed consent form will be available after publication.
+https://www.finlay.edu.cu/blog/category/sala-cientifica/
 ) 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 7 days after dose.
 ) 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 dose .
-) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Day 7, 14 and 28.
+) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Prevaccination, Day 7, 14 and 28 after vaccination.
-) Neutralizing antibody titer: Measurement time: Day 0 and 28.
+) Neutralizing antibody titer: Measurement time: Prevaccination and day 14 after vaccination.
-)% ACE2-RBD inhibition: Measurement time: Day 0, 7, 14 and 28.
+)% ACE2-RBD inhibition: Measurement time: Prevaccination, 7, 14 and 28 days after vaccination.
+)Cellular Immunity prevaccination and 28 days after vaccination.
--04-26T00:00:00
+-03-04T00:00:00
-/02/13
+/04/27
-/02/13
+/04/27
+sites/default/files/Final Report.pdf

SOBERANA 01B

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 01B

Scientific title:

Phase I study, open, adaptive and monocentric, to evaluate the safety, reactogenicity and explore the immunogenicity of the prophylactic vaccine candidate FINLAY-FR-1A against SARS-CoV-2, in convalescent of COVID-19.

Acronym of Scientific Title:

SOBERANA 01B

Secondary indentifying numbers:

IFV/COR/07

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 :

30/12/2020

Reference number:

542/05-017-20BA

Principal investigator

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

First name:

Arturo

Last name:

Chang Monteagudo

Medical Specialty :

First degree specialist in Integral General Medicine. First degree specialist in Immunology

Affiliation:

Institute of Hematology and Immunology

Postal address:

8 street bw/17 and 19. Vedado, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78461146

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:

Complete

Date of first enrollment:

09/01/2021

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:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Disease Prevention

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

FINLAY-FR-1A Experimental Group: 50 μg of RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Single Dose

Intervention keyword:

FINLAY-FR-1A

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):

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 dose.

Key secondary outcomes:

1) 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 7 days after dose. 2) 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 dose . 3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Prevaccination, Day 7, 14 and 28 after vaccination. 4) Neutralizing antibody titer: Measurement time: Prevaccination and day 14 after vaccination. 5)% ACE2-RBD inhibition: Measurement time: Prevaccination, 7, 14 and 28 days after vaccination. 6)Cellular Immunity prevaccination and 28 days after vaccination.

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:

59 years

Inclusion criteria:

1. Subjects who give their written informed consent to participate in the study. 2. Subjects aged between 19 and 59 years. 3. Body mass index between 18.5 and 29.9 kg / m2. 4. Women of childbearing potential use safe contraceptive methods during the study.

Exclusion criteria:

1. Subjects with a history of COVID-19 who meet any of the following criteria: a) Current history of infection or having received a medical discharge for SARS-CoV 2 during the 2 months prior to recruitment. b) History of severe clinical picture due to COVID-19, according to your medical history or obtained during the medical interview. c) Baseline antibody levels showing a ≥60% inhibition of RBD binding to its receptor. 2. 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. 3. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 4. Subjects with chronic non-communicable diseases that are NOT controlled, according to clinical or laboratory criteria established for each entity in the Cuban medical standards (Ex: bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid diseases , neurological, hemolymphopoietic system, liver failure, kidney failure, psychiatric illness at a psychotic level, among others). 5. Subjects with congenital or acquired immune system disease. 6. Subjects with a history of neoplastic disease. 7. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except smoking. 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. 11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months. 12. Application of another vaccine in the last 30 days. 13. Treatment with immunomodulators in the last 30 days, eg; steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study. 14. History of having received a blood transfusion or blood products in the last 3 months. 15. Subjects with difficulties in attending the planned follow-up consultations. 16. Splenectomy or splenic dysfunction. 17. Pregnancy, puerperium or lactation. 18. Subjects with tattoos in the deltoid region of both arms. 19. Subjects with positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus and VDRL serology.

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:

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:

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:

Rolando

Middle Name:

Felipe

Last Name:

Ochoa Azze

Specialty:

Second degree specialist in Immunology. Doctor of Medical Science

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 :

ochoa@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Hematology and Immunology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

29/10/2020

Postal address of Ethic Committee :

8 street, 460 between 17 and 19. Vedado, Plaza de la Revolucion, ZC:10400. Havana, Cuba.

Telephone:

+53-78461146

Email:

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

13/02/2021

Date of available results:

26/03/2021

Date of first publication:

04/03/2021

Results Study

Section to complete the data related to the summarized results.

Results file:

Final Report.pdf

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:

RPCEC00000349

Date of Registration in Primary Registry:

05/01/2021

Record Verification Date:

2021/04/27

Next update date:

2022/04/27

Link to the spanish version:

Click here

Registered Trials

Registration process

SOBERANA 01B

About the RPCEC

Useful resources