Evaluation of the safety and immunogenicity of the vaccine candidate "ABDALA" in children and adolescents

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:

Ismaelillo

Scientific title:

Phase I / II, randomized, parallel group clinical trial to evaluate the safety and immunogenicity in apparently healthy adolescents and children of the vaccine candidate "ABDALA" for the prevention of COVID-19.

Acronym of Scientific Title:

FI / II-ABDALA-Children and adolescents

Secondary indentifying numbers:

IG/CIGB-66I/CVD19/2104

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP); Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

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:

Sonia

Last name:

Resik Aguirre

Medical Specialty :

Doctor in medicine. Second degree specialist in Microbiology. Doctor of Medical Sciences. Doctor of Science. Master in Virology. Senior Researcher. Titular teacher.

Affiliation:

Institute of Tropical Medicine "Pedro Kouri" (IPK)

Postal address:

Avenida Novia del Mediodia, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email address:

sresik@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:

Camagüey, Provincial Center of Hygiene Epidemiology and Microbiology (CPHEM), Alina Tejeda Fuentes, First degree specialist in Comprehensive General Medicine and Hygiene and Epidemiology

Camagüey, Polyclinic "Ignacio Agramonte", Yubisleidys Rodríguez Fernández, First degree specialist in Comprehensive General Medicine

Camagüey, University Polyclinic "Julio Antonio Mella", Liliana Aguilar Soto, First degree specialist in Comprehensive General Medicine

Camagüey, Teaching Community Polyclinic "Previsora", Arelys Guerra de La Vega, First degree specialist in Comprehensive General Medicine

Camagüey, North Polyclinic "Joaquín de Aguero", Eduardo Álvarez Márquez, First degree specialist in Comprehensive General Medicine

Camagüey, Community Teaching Polyclinic “Tula Aguilera” (West Polyclinic), Lidia Elvira Díaz López, First degree specialist in Comprehensive General Medicine

Camagüey, Comprehensive Polyclinic “Rodolfo Ramírez Esquivel” (PIRRE Polyclinic), Doris Mejías Reyes, First degree specialist in Comprehensive General Medicine

Camagüey, Teaching Polyclinic “José Martí Pérez” (Center Polyclinic), Nilda Rodríguez Ballester, First degree specialist in Comprehensive General Medicine

Camagüey, Teaching Polyclinic "Carlos J. Finlay", María K. Carmenate Gutiérrez, First degree specialist in Comprehensive General Medicine

Camagüey, Community Polyclinic East, Magalys de la Caridad González Hernández, First degree specialist in Comprehensive General Medicine

Camagüey, Provincial Pediatric Hospital “Eduardo Agramonte Piña”, Ileana Mesa Pedroso, First degree specialist in Pediatrics and Comprehensive General 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:

20/07/2021

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):

Vaccine Candidate Abdala Group I (Experimental): (RBD 25 mcg + aluminum hydroxide 0,30 mg)/0,5 mL, by intramuscular route in the deltoid region, schedule 0-14-28 days Group II (Experimental): (RBD 50 mcg + aluminum hydroxide de 0,30 mg)/0,5 mL or by intramuscular route in the deltoid region, schedule 0-14-28 days

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Intervention keyword:

Vaccine candidate Abdala

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):

1. Percentage of serious adverse events related to the investigational product (Adverse events classified as serious with a causal association consistent with vaccination according to the Cuban vaccine pharmacovigilance system). Measurement time: up to 28 days after the third dose. 2. Proportion of subjects with seroconversion of SARS-CoV-2 anti-RBD IgG antibodies (Considering seroconversion as ≥ 4 times the initial determination of the antibody titer). Measurement time: day 56.

Key secondary outcomes:

1. Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Seriousness of adverse events (Serious, Not serious), -Causality relationship (causal association consistent with vaccination, Indeterminate, Inconsistent causal association with vaccination, not classifiable), - Result (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: 1, 24, 48 and 72 hours and, 7 days after the administration of each dose, 14 days after the administration of the 1st and the 2nd dose, respectively, and up to 28 days after the 3rd dose of the vaccine candidate. 2. Inhibition to ACE2 by ELISA. Measurement time: days 0 and 56. As a variable for exploration: 3. Percentage of SARS-CoV-2 viral neutralization response. Measurement time: Day 56. (Only 10% of those with ≥ 30% inhibition to ACE2 will be evaluated by ELISA at a 1/100 dilution of the sample).

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. Participation on a voluntary basis (signing of the Informed Consent by parents or legal guardians with legal and mental capacity to represent the minor, as well as the signing of the Informed Consent for participants over 12 years of age). 2. Female or male sex and ages between 3 and 18 years at the time of inclusion. 3. Apparently healthy child or adolescent, based on medical history, physical examination, and evaluation by the investigating pediatrician. 4. Nutritional assessment: Weight / height between 10 and 90 percentile for children between 3 and 9 years old. Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years. According to the cut-off points for the Cuban pediatric population. 5. Laboratory tests within or outside the reference range, but not clinically significant (Phase I only).

Exclusion criteria:

1. Reported or documented history of SARS-CoV-2 infection. 2. Contact or suspect of COVID-19 at the time of inclusion. 3. Body temperature equal to or greater than 37ºC. It will be possible to wait until 48 hours after the date in which the vaccination corresponds to apply it. 4. Acute infectious disease at the time of the vaccine application or in the three days prior to the administration of the vaccine. 5. History of chronic diseases. 6. Children with a history of allergic diseases or diseases of the immune system. 7. History of having received a vaccine against SARS-CoV-2 or against other coronaviruses. 8. Have received any other vaccine, in the 14 days prior to the administration of each dose. 9. Use of any investigational product within 30 days prior to recruitment, or planned for during the study period. 10. Having been treated within the previous 30 days or the possibility of requiring treatment during the trial for any underlying condition with: immunomodulators (eg some type of Interferon, Transfer factor, Biomodulin T, Immunoferon, thymosin), or with steroids by any route of administration, or with cytostatics. 11. Have received blood, or any blood product within the three months prior to inclusion. 12. Allergy to Thimerosal or any other component of the formulation under study. 13. Pregnancy or breastfeeding. Positive urine pregnancy test, before the administration of any of the three doses in female participants who are biologically capable of having a pregnancy (history of menarche). 14. Tattoos in both deltoid regions that make it difficult to see the injection site. 15. History or suspicion of alcoholism or drug dependence.

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:

Randomized trial

Masking:

Double Blind

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1-2

Target sample size:

592

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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Medical doctor. First degree specialist in Clinical Biochemistry; Master in Clinical Trials.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72087421 (Ext 133)

Email :

zurina.cinza@cigb.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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Medical doctor. First degree specialist in Clinical Biochemistry; Master in Clinical Trials.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72087421 (Ext 133)

Email :

zurina.cinza@cigb.edu.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

Provincial Center of Hygiene Epidemiology and Microbiology

Institute of Tropical Medicine "Pedro Kouri" (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

15/06/2021

Postal address of Ethic Committee :

General Gomez No. 5 e/ Republica y Avellaneda, ZC: 70700. Camaguey, Cuba

Autopista Novia del Mediodia km 6½, La Lisa. ZC: 11400, Havana, Cuba

Telephone:

+53-32296545; +53-32298784

+53-72020425

Email:

yamillkacphe.cmw@infomed.sld.cu

ericm@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

15/10/2021

Date of available results:

30/10/2021

Date of first publication:

15/11/2021

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:

RPCEC00000381

Date of Registration in Primary Registry:

01/07/2021

Record Verification Date:

2021/07/07

Next update date:

2022/07/07

Link to the spanish version:

Click here [3]