SOBERANA PEDIATRIA

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 PEDIATRIA

Scientific title:

Phase I-II study, sequential during phase I, open-label, adaptive and multicenter to evaluate the safety, reactogenicity and immunogenicity, of a heterologous two-dose schedule of the prophylactic anti-SARS vaccine candidate - CoV-2, FINLAY-FR- 2 and a dose of FINLAY-FR-1A, in Cuban children and adolescents. (COVID-19)

Acronym of Scientific Title:

SOBERANA PEDIATRIA

Secondary indentifying numbers:

IFV/COR/12

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)

Authorization date :

10/06/2021

Reference number:

05.010.21BA

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 [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, Pediatric Hospital "Juan Manuel Marquez", Maria Elena Mesa Herrera, 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:

Complete

Date of first enrollment:

14/06/2021

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:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A. FINLAY-FR-2: 25 µg of RBD-TT, by intramuscular route, 0.5 mL, in scheme 0 - 28 days. FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramuscular route, 0.5 mL as dose booster 56 days.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

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: 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. Phase II: Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70

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 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) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70. 4) Neutralizing antibody titer: Measurement time: Day 42 and 70. 5) % ACE2-RBD inhibition: Measurement time: Day 0, 42 and 70. 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 each 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 each dose . 4) Neutralizing antibody titer: Measurement time: Day 42 and 70. 5) % ACE2-RBD inhibition: Measurement time: Day 0, 42 and 70.

Selection criterias

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

Gender:

Male/Female

Minimum age:

3 years

Maximum age:

18 years

Inclusion criteria:

1. Subjects aged between 3 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects 3-11 years old: 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 3 and 9 years of age) or the Body Mass Index 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).

Exclusion criteria:

1. Subjects with acute febrile or infectious disease at the time of the vaccine application or in the 7 days prior to its administration. 2. Subjects that meet any of the following criteria: a) Previous or current history of SARS-CoV 2 infection. b) SARS-CoV 2 PCR positive. c) Be declared in the category of contact or suspect at the time of inclusion. 3. Subjects with a history of hypersensitivity to Thiomersal or any of the components of the formulations. 4. Subjects with a history of having been immunized with a SARS-CoV 2 vaccine. 5. Subjects with a history of having received a vaccine from the Cuban immunization scheme, in a period of less than 30 days prior to the administration of the product under investigation. 6. Use of any investigational product in the 30 days prior to immunization. 7. Application of vaccines containing tetanus toxoid in the last 3 months. 8. History of chronic diseases. 9. Subjects with a history of major congenital malformations (defects that have a significant functional compromise for the individual's life, have medical consequences and require early, sometimes urgent, care). 10. Primary or secondary immune system disease. 11. History of neoplastic disease. 12. History of severe allergic reactions. 13. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Levamisole). 14. Subjects with a history of Convulsive Disease. 15. History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months. 16. Splenectomy or splenic dysfunction. 17. Child with a minor or mentally disabled mother or father. 18. Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate). 19. Subjects with tattoos in the deltoid region of both arms. 20. Subjects with a history or positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus or VDRL serology. 21. History of psychoactive substance use in the last 6 months.

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:

350

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 [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:

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 [3]

Research Ethics Committees

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

Name of Research Ethics Committees:

Pediatric Hospital "Juan Manuel Marquez"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

25/05/2021

Postal address of Ethic Committee :

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

Telephone:

+53-72606140

Email:

direccionjmm@pejm.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

350

Study completion date:

07/10/2021

Date of available results:

20/02/2022

Date of first publication:

31/01/2022

Results Study

Section to complete the data related to the summarized results.

Results file:

RPCEC00000374-En.pdf [4]

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:

RPCEC00000374

Date of Registration in Primary Registry:

10/06/2021

Record Verification Date:

2022/04/01

Next update date:

2023/04/01

Link to the spanish version:

Click here [5]