SOBERANA PLUS PEDIATRIA

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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 PEDIATRIA

Scientific title:

Phase I / II, open-label, adaptive study to evaluate the safety, reactogenicity and immunogenicity of the prophylactic vaccine candidate FINLAY-FR-1A against SARS-CoV-2, in convalescent of COVID-19 in pediatric age (COVID-19)

Acronym of Scientific Title:

SOBERANA PLUS PEDIATRIA

Secondary indentifying numbers:

IFV/COR/15

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (IFV)

Source(s) of monetary or material support:

Finlay Vaccine Institute (IFV); Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and Enviroment CITMA)

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:

In process

Principal investigator

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

First name:

Rinaldo

Last name:

Puga Gomez

Medical Specialty :

Second Degree Specialist in Pediatrics

Affiliation:

Central Clinic "Cira Garcia"

Postal address:

18th Street No. 4304 corner Av 43. Miramar

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72042811

Email address:

puga@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:

Havana, Pediatric Hospital "Juan Manuel Marquez", Maria Elena Mesa Herrera, MD. Second degree specialist in Pediatrics. Assistant Professor

Cienfuegos, Pediatric Hospital "Paquito Gonzalez Cueto", Dunia Maria Chavez Amaro, MD. Second degree specialist in Pediatrics. Assistant Professor

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

29/09/2021

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

Respiratory Tract Diseases

Disease Prevention

Pediatrics

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

Experimental Group SOBERANA PLUS: 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

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):

Phase I: 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: 28 days after dose. Phase II 1) Molecular inhibition titer (mVNT50). Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).

Key secondary outcomes:

Phase I: 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 3 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 to pre-vaccination). Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 4) Neutralizing antibody titer: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 5) % ACE2-RBD inhibition: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 6) Molecular inhibition titer (mVNT50). Measurement time: Day 14 or 28 (random distribution of the study sample between the two times). Phase II: 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. 2) 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 3 days after dose. 3) 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. 4) Neutralizing antibody titer: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 5) % ACE2-RBD inhibition: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 6) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 14 or 28 (random distribution of the study sample between the two times).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

2 years

Maximum age:

18 years

Inclusion criteria:

1. Subjects aged between 2 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects aged 2-11 years: Informed consent of parents or legal guardians. - Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent. 3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 2 and 9 years of age) or the BMI between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population. 4. General, regional and apparatus physical examination without alterations. 5. Laboratory results within or outside the range of reference values but not clinically significant (For the subjects to be included in phase I). 6. 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 have received a medical discharge for SARS-CoV 2 in the two months prior to recruitment. b) History of critical clinical picture due to COVID-19, according to your medical history or obtained during the medical interview. 2. Subject with a history of having received any dose of vaccine candidates or vaccines against SARS - CoV - 2. 3. 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. 4. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 5. 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, liver failure, kidney failure , psychiatric illness at a psychotic level, among others). 6. Subjects with congenital or acquired immune system disease. 7. Subjects with a history of neoplastic disease. 8. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except smoking. 9. Subjects with diminished mental faculties. 10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 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 to the determinations of HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody and VDRL Serology. (For Phase I)

Type of population:

Children

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:

1-2

Target sample size:

520

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 between 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:

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 between 198 and 200 Atabey, Playa

City:

Havana

Country:

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:

Pediatric Hospital "Paquito Gonzalez Cueto"

Pediatric Hospital "Juan Manuel Marquez"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/09/2021

17/09/2021

Postal address of Ethic Committee :

Street 39 # 3602 e/ 36 y 38. ZC:55100. Cienfuegos. Cuba

31 Av. corner 76, Marianao, Havana, ZC 11500, Cuba

Telephone:

+53-043-516151

+53-72606140

Email:

director@hosped.cfg.sld.cu

direccionjmm@pejm.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

19/11/2021

Date of available results:

03/12/2021

Date of first publication:

31/01/2022

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:

RPCEC00000391

Date of Registration in Primary Registry:

28/09/2021

Record Verification Date:

2021/09/28

Next update date:

2022/09/28

Link to the spanish version:

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SOBERANA PLUS PEDIATRIA

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