To evaluate the immunogenicity and safety of SOBERANA® 02 and SOBERANA® Plus as booster of immunity against the omicrom variant of SARS-CoV-2, in adult subjects

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.

Scientific title:

Post - authorization study to evaluate the immunogenicity and safety of SOBERANA® 02 and SOBERANA® Plus as a booster of immunity against the omicron variant of sars-cov-2, in adult subjects.

Secondary indentifying numbers:

IFV/COR/17

Issuing authority of the secondary identifying numbers:

Finlay Institute of Vaccines (IFV)

Source(s) of monetary or material support:

FONCI (Financial Fund for Science and Innovation)

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

Second Degree Specialist in Epidemiology

Affiliation:

Institute of Tropical Medicine "Pedro Kourí"

Postal address:

Novia del Mediodía km 6 1/2, Arroyo Arenas, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

17100

Telephone:

+53-72020427 ext. 3204

Email address:

mariaeugenia@ipk.sld.cu [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:

Havana, Clínica 1, La Lisa, PhD 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:

Pending

Date of first enrollment:

22/05/2023

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:

COVID-19

Infecciones por Coronavirus

Infecciones por Coronaviridae

Infecciones por Nidovirales

Infecciones

Neumonía viral

Neumonía

Enfermedades Pulmonares

Infecciones del Sistema Respiratorio

Infecciones Respiratorias

Intervention(s):

Group 1: They will be administered a single booster dose (0.5 mL, IM) of the SOBERANA®02 vaccine. Group 2: They will be administered a single booster dose (0.5 mL, IM) of the SOBERANA® Plus vaccine.

Intervention code:

COVID-19 Vaccines

Immunization, Secondary

Immunogenicity, Vaccine

Immunotherapy, Active

Disease Prevention

Single Dose

Injections, Intramuscular

Intervention keyword:

Soberana 02, 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):

Neutralizing antibody titers: Viral neutralization assay. Measurement time: 0, 28 days, 6 months and one year

Key secondary outcomes:

1- Anti-RBD specific IgG antibody levels: UMELISA SARS-CoV-2 ANTI S for the quantification of IgG antibodies directed against the RBD protein of SARS-CoV-2. Measurement time: 0, 28 days, 6 months and one year. - Percentage of ACE2 inhibition: RBD:ACE2 interaction inhibition ELISA. Measurement time: 0, 28 days, 6 months and one year. 2 - Concentration of anti-TT IgG antibody: ELISA for determination of anti-TT IgG. Measurement time: 0 and one year. 3 - Determination of anti-RBD specific T cell populations: Assessment of the specific T response to the RBD by intracellular cytokine staining and multiparameter flow cytometry. Measurement time: 0, 28 days, 6 months and one year. 4 - Anti-SARS-CoV-2 N Protein IgG antibody concentration: quantitative indirect ELISA to determine anti-SARS-CoV-2 N Protein IgG antibody levels. Measurement time: 0, 28 days, 6 months and one year. 5 - Variables related to safety: Adverse Event (AE) Requested, Unsolicited. 6 - Requested AE (Any sign or symptom that appears after vaccination and up to 7 days after it is declared as requested AE). Description of the AE (Any sign or symptom that appears after vaccination and up to 7 days declared as requested AE), Duration of the AE (less than 24 hours, from 24 to 48 hours, more than 48 to 72 hours, more than 72 hours), AE Onset (less than 60 minutes, 60 minutes to 24 hours, more than 24 to 48 hours, more than 48 to 72 hours, more than 72 hours), AE Intensity (Mild, Moderate, Severe) , AE Severity (Serious, Non-severe), AE Outcome (Recovered, Recovered with sequelae, Persists, Death, Unknown), Causal relationship (Causal association consistent with vaccination, Undetermined, Causal association inconsistent with vaccination, Not classifiable ). Measuring time: 0, 28 days, 6 months and one year 7 - Unsolicited AE (Any sign or symptom that appears after vaccination and within 28 days, that is not within the AE requested.) Description of the AE (Any sign or symptom that appears after vaccination and up to 7 days declared as Requested EAs), EA Duration (less than 24 hours, from 24 to 48 hours, more than 48 to 72 hours, more than 72 hours), EA Appearance (less than 60 minutes, from 60 minutes to 24 hours, more than 24 up to 48 hours, more than 48 up to 72 hours, more than 72 hours), AE Intensity (Mild, Moderate, Severe), AE Severity (Serious, Not Serious), AE Outcome (Recovered, Recovered with sequelae, Persists, Death, Unknown), Causal relationship (Causal association consistent with vaccination, Undetermined, Causal association inconsistent with vaccination, Not classifiable). Measurement time: 0, 28 days, 6 months and one year.

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:

None

Inclusion criteria:

1. Subjects of both sexes, over 18 years of age. 2. Subjects who give their informed consent to participate in the study. 3. Subjects who received the primary vaccination schedule against SARS-CoV-2 or convalescent subjects from COVID-19 in a period greater than or equal to 6 months.

Exclusion criteria:

1. Subjects with febrile or acute infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application. 2. Subjects with chronic diseases NOT controlled, according to clinical criteria. 3. Subjects with a history of severe allergy (anaphylactic shock, angioneurotic edema, edema of the glottis, severe urticaria) to SOBERANA® 02 and SOBERANA® Plus vaccines. 4. Subjects convalescent from COVID-19 in a period of less than 6 months. 5. Having received a booster dose against SARS-CoV-2 in less than 6 months. 6. Application of another vaccine in the last 30 days. 7. Previous vaccination with tetanus toxoid vaccine in a period of less than 6 months. 8. History of having received a transfusion of blood or blood products in the last 3 months. 9. Women of childbearing age with a history of amenorrhea greater than 4 weeks or pregnant.

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:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

N/A

Target sample size:

306

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:

Lelyhana

Last Name:

Verdecia Sanchez

Specialty:

First Degree Specialist in Internal Medicine

Affiliation:

Clinica1, La Lisa

Postal Address:

calle 27 e/ 184 y 202. La Coronela. La Lisa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72720094

Email :

leslyverdecia@infomed.sld.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:

Maria

Middle Name:

Eugenia

Last Name:

Toledo Romani

Specialty:

Second Degree Specialist in Epidemiology

Affiliation:

Institute of Tropical Medicine "Pedro Kourí"

Postal Address:

Novia del Mediodía, Km 6 ½, La Lisa.

City:

Havana

Country:

Cuba

Zip Code:

17100

Telephone:

+53-72020427

Email :

mariaeugenia@ipk.sld.cu [1]

Research Ethics Committees

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

Name of Research Ethics Committees:

National Center for Toxicology (CENATOX)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/05/2023

Postal address of Ethic Committee :

Av. 31 and 114 street, Marianao, Havana, Cuba

Telephone:

+53-72608751

Email:

cenatox@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/05/2024

Date of available results:

29/06/2024

Date of first publication:

17/11/2024

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:

RPCEC00000424

Date of Registration in Primary Registry:

19/05/2023

Record Verification Date:

2023/05/19

Next update date:

2024/05/19

Link to the spanish version:

Click here [3]