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)

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 [1]

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 [2]

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 [3]

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:

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:

Click here [4]