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SOBERANA PLUS TURIN
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19 November 2021 - 9:55pm
by FINLAY
21 July 2022 - 8:34am
by FINLAY
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Changes to
Authorization date
-
+
2021-11-12 00:00:00
Changes to
Reference number
-
In process
+
536/05.038.21BA
Changes to
Recruitment status
-
Pending
+
Complete
Changes to
Final enrolment number
-
+
30
Changes to
Specialty
-
Second degree specialist
in Immunology. PhD in Medical
Science
+
MD, Specialist
in Immunology. PhD in Medical
Sciences
Revision of 21 July 2022 - 8:34am:
SOBERANA PLUS TURIN
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 PLUS TURIN
Scientific title:
Exploratory study of the SOBERANA Plus ST vaccine, to evaluate its reactogenicity and immunogenicity in adults from Italy: COVID-19 convalescents; and subjects without a history of this disease and previously immunized against SARS-CoV-2. (COVID-19)
Acronym of Scientific Title:
SOBERANA PLUS TURIN
Secondary indentifying numbers:
IFV/COR/16
Issuing authority of the secondary identifying numbers:
Finlay Vaccine Institute (IFV)
Primary sponsor:
Finlay Vaccine Institute (IFV)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and Environment
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 :
12/11/2021
Reference number:
536/05.038.21BA
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Vladimir
Midle name:
Daniel
Last name:
Trujillo Machado
Medical Specialty :
Internal Medicine Physician
Affiliation:
International Health Center “La Pradera”
Postal address:
Calle 15 No. 22210 entre 222A y 234, Siboney, Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72725273
+53-72731441
Email address:
vladimirtrujillo71@gmail.com
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:
16/11/2021
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
Nidovirales Infections
Betacoronavirus
Aftercare
Health condition keyword:
COVID-19
SARS-CoV2
Intervention(s):
SOBERANA Plus ST: 50 μg of d-RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose. The vaccine will be applied to two groups of italian patients: a) Group of convalescents. b) Group of adults vaccinated with another vaccine against COVID-19
Intervention code:
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccines
Injections, Intramuscular
Single Dose
Intervention keyword:
SOBERANA Plus
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 and day 28 after vaccination. 4) % ACE2-RBD inhibition and Half-maximal molecular virus neutralization titer (mVNT50). Measurement time: Prevaccination, and day 28 after vaccination. 5) Viral Neutralization antibody titers against variants of concerns: Measurement time: Prevaccination and day 28 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. The participant understands and agrees to comply with the study procedures and provides written informed consent. 2. Adults, 19 to 59 years of age, at time of consent. 3. Subjects with BMI of 18.5 to 34.9 kg/m2.
Exclusion criteria:
1. A) COVID-19 convalescent group: a) A history of SARS-CoV-2 infection at time of recruitment or medical discharge for COVID-19 during the two months before recruitment; b) History of severe or asymptomatic COVID-19. B) Group of healthy individuals immunized with another vaccine: History of COVID-19. 2. Acute illness, febrile, 7 days prior to administration of investigational product or at screening. 3. Current use of any prescription of non-steroidal anti-inflammatory drugs (NSAIDs) or antimicrobial medications within 7 days prior to vaccination. 4. Any chronic medical disease or condition that, in the opinion of the clinical investigator, precludes study participation (e.g., subjects with respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), diabetes mellitus, thyroid disease, cardiovascular disease (e.g., congestive heart failure, hypertension, and ischemic heart disease), liver and kidney chronic diseases, neurological conditions or bleeding disorder, psychiatric condition, etc.). 5. Any primary or secondary immunodeficiency. 6. Ongoing malignancy or recent diagnosis of malignancy. 7. A history of alcohol abuse or other recreational drug use within 30 days before the first vaccine administration, except smoking. 8. Demonstrated inability to comply with the study procedures (Mental problems or disorders). 9. A history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticarial, angioedema,). 10. A history of hypersensitivity to some vaccine component. 11. Participated in another investigational study involving any investigational product within 3 month prior to the day of enrollment. 12. A) COVID-19 convalescent group: a) Subjects vaccinated with any vaccine against SARS-CoV-2. B) Group of healthy individuals previously immunized with another vaccine: Subjects are excluded if they were not vaccinated between 3 and 12 months before recruitment. 13. Received any vaccine within 30 days prior to the day of enrollment. 14. Received systemic immunosuppressant or immune-modifying drugs, including cytostatic drugs and steroids. 15. History of transfusion of blood or blood products in the last 3 months. 16. Difficulties to comply with the schedule of clinical visit or to continue follow up clinical visits. 17. Splenectomy or splenic dysfunction. 18. Women of childbearing potential not using safe contraceptive methods during the study 19. Pregnancy, puerperium, or breastfeeding. 20. Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (both deltoid region).
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:
Non-randomized controlled trial
Masking:
Open
Control group:
Uncontrolled
Study design:
Parallel
Phase:
N/A
Target sample size:
Until 30 volunteers by 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:
Yanet
Last Name:
Climent Ruiz
Specialty:
PhD in Biological 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 :
ycliment@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:
MD, Specialist in Immunology. PhD in Medical 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 :
ochoa@finlay.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Yes
Description of Data Sharing Plan:
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.
Additional information to share:
The Study protocol, statistical analysis plan, and the informed consent form will be available after publication.
URL for additional information:
https://www.finlay.edu.cu/blog/soberana-plus-convalecientes/
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
International Health Center La Pradera
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
19/10/2021
Postal address of Ethic Committee :
Calle 230 entre 15A y 17, Siboney, La Habana. Cuba
Telephone:
+53-72737467 ext 368
Email:
relacinternac@cislapradera.cu
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
30
Study completion date:
14/12/2021
Date of available results:
31/01/2022
Date of first publication:
31/03/2022
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:
RPCEC00000397
Date of Registration in Primary Registry:
12/11/2021
Record Verification Date:
2021/11/19
Next update date:
2022/11/19
Link to the spanish version:
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