Revisiones para SOBERANA 01A | Registro Público Cubano de Ensayos Clínicos

--- 23 Noviembre 2020 - 3:30pm por FINLAY
+++ 18 Agosto 2021 - 12:12pm por FINLAY
-In process
+.013.20BA
-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: vicente.verez@finlay.edu.cu. These proposals must be reviewed and approved by the sponsor and investigator. Finally, data access agreement must be signed.
 ) 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 each 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 each dose .
-) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Day 28, 42 and 56 for all groups and, day 84 for group 3.
+) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Day 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.
-) Neutralizing antibody titer: Measurement time: Day 0 and 56 for all groups and, day 84 for group 3.
+) Neutralizing antibody titer: Measurement time: Day 0 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.
-)% ACE2-RBD inhibition: Measurement time: Day 0, 28, 42 and 56 for all groups and, day 84 for group 3.
+)% ACE2-RBD inhibition: Measurement time: Day 0, 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.
-Group 1- FINLAY-FR-1 (Experimental): High dose of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
+Group 1- FINLAY-FR-1 (Experimental): High dose of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose.This group will be subdivided in two subgroups: one will be boosted with the same vaccine (homologous schedule) or with FINLAY-FR-1A (high dose) (heterologous schedule). Presentation: Vial with single dose.
-Group 2- FINLAY-FR-1A (Experimental): High dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
+Group 2- FINLAY-FR-1A (Experimental): High dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose. Presentation: Vial with single dose.
 Group 3- FINLAY-FR-1A (Experimental): Low dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28-56 days. Presentation: Vial with single dose.
-/11/23
+/08/18
-/11/23
+/08/18

SOBERANA 01A

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 01A

Scientific title:

Phase I, randomized, double-blind and adaptive study to evaluate the safety, reactogenicity and explore the immunogenicity of different formulations of the Prophylactic Vaccine Candidates against SARS - CoV - 2, FINLAY- FR-1 and FINLAY- FR-1A (COVID-19).

Acronym of Scientific Title:

SOBERANA 01A

Secondary indentifying numbers:

IFV/COR/05

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:

05.013.20BA

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

País:

Cuba

Zip Code:

11500

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:

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:

19/10/2020

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

Disease Prevention

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group 1- FINLAY-FR-1 (Experimental): High dose of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose.This group will be subdivided in two subgroups: one will be boosted with the same vaccine (homologous schedule) or with FINLAY-FR-1A (high dose) (heterologous schedule). Presentation: Vial with single dose. Group 2- FINLAY-FR-1A (Experimental): High dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose. Presentation: Vial with single dose. Group 3- FINLAY-FR-1A (Experimental): Low dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28-56 days. Presentation: Vial with single dose.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Meningococcal Vaccines

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.

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 each 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 each dose . 3) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Day 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2. 4) Neutralizing antibody titer: Measurement time: Day 0 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2. 5)% ACE2-RBD inhibition: Measurement time: Day 0, 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.

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 informed consent to participate in the study by writing. 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. 5. General, regional and apparatus physical examination: normal or without clinically significant alterations. 6. Laboratory results within or outside the range of reference values but not clinically significant

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 antimicrobial treatment in the 7 days prior to the administration of the vaccine. 3. Subjects with chronic non-communicable 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 abuse of toxic substances during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics and 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 or to some of the components of the formulation. 11. Subjects with a history of SARS-CoV 2 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 specific antibodies to SARS-CoV 2. d) Patient with PCR positive for SARS-CoV 2. 12. Participation in another clinical trial in the last 3 months. 13. Application of another vaccine in the last 30 days. 14. Application of the VA-MENGOC-BC vaccine in the last 3 months. 15. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, Thymosin) or predictably those people that due to their underlying disease require immunomodulatory treatment, which may coincide during the development of the study. 16. Transfusion of blood or blood products in the last 3 months. 17. Subjects with difficulties in attending the planned follow-up consultations. 18. Splenectomy or splenic dysfunction. 19. Pregnancy, puerperium or lactation. 20. Subjects with tattoos in the deltoid region on both arms. 21. Subjects positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or syphilis specific antibody.

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:

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

País:

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 bw/ 198 and 200 Atabey, Playa

City:

Havana

País:

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:

12/10/2020

Postal address of Ethic Committee :

Avenue 31 and 114, Marianao. Havana, ZC 11500, Cuba

Telephone:

+53-72603252

Correo electrónico:

cenatox@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

31/01/2021

Date of available results:

15/02/2021

Date of first publication:

28/02/2021

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:

RPCEC00000338

Date of Registration in Primary Registry:

17/10/2020

Record Verification Date:

2021/08/18

Next update date:

2022/08/18

Link to the spanish version:

Click here

Ensayos Registrados

Proceso de Registro

SOBERANA 01A

Acerca del RPCEC

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