Revisions for MEÑIQUE Study | Registro Público Cubano de Ensayos Clínicos

--- 3 September 2021 - 12:38pm by Gladys
+++ 29 May 2024 - 4:36pm by CIGB
-In process
+/05.030.21BA
-Pending
+Complete
-Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time.
+) Safety - Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (consistent with vaccination, indeterminate, inconsistent with vaccination, not classifiable), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the application of each dose of the vaccine and in the first hour after the inoculation of the product (in each dose), and on the 7th day after the first dose.
+) A non-inferiority immunobridging study to extrapolate the efficacy of the Abdala vaccine in paediatric ages of 3-18 years, from immunogenicity results based on the evaluation of neutralizing antibodies (NAb) against SARS-CoV-2. The design followed basic principles for this type of analyses according WHO guidelines.
-First and second grade specialist in Pediatrics.
+Doctor in Medical Sciences; 1st and 2nd degree specialist in Pediatrics.
-) Safety - Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (consistent with vaccination, indeterminate, inconsistent with vaccination, not classifiable), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the application of each dose of the vaccine and in the first hour after the inoculation of the product (in each dose), and on the 7th day after the first dose.
+) Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time.
 ) Inhibition to ACE2 (by ELISA - Enzyme-linked immunosorbent assay). Measurement time: at 42 (+3 days) with respect to baseline time.
 ) SARS-CoV-2 viral neutralization response percentage (only 10% of those samples that have ≥ 30% inhibition at a 1/100 dilution will be evaluated in the RBD-ACE-2 binding neutralization assay ). Measurement time: at 42 (+3 days) with respect to baseline time.
--10-29T00:00:00
+-11-02T00:00:00
--12-14T00:00:00
+-08-11T00:00:00
--12-29T00:00:00
+-10-15T00:00:00
-Minimum 700
-/09/03
+/05/29
-/09/03
+/05/29

MEÑIQUE Study

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:

Safety and immunogenicity of the Abdala vaccine in pediatric ages. (COVID-19)

Secondary indentifying numbers:

IG/CIGB-66I/CVD19/2105

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana.

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:

399/05.030.21BA

Principal investigator

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

First name:

Laura

Last name:

Alvare Alvare

Medical Specialty :

Doctor in Medical Sciences; 1st and 2nd degree specialist in Pediatrics.

Affiliation:

Surgical Medical Research Center (CIMEQ)

Postal address:

Calle 216 y 11B, Playa

City:

Havana

Country:

Cuba

Zip Code:

6096

Telephone:

+53-72718424

Email address:

laura.alvare@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:

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:

13/09/2021

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:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Abdala - protein subunit COVID-19 vaccine (RBD 50 mcg + 0.30 mg aluminum hydroxide): 0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days).

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Intervention keyword:

Vaccine 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) Safety - Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (consistent with vaccination, indeterminate, inconsistent with vaccination, not classifiable), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the application of each dose of the vaccine and in the first hour after the inoculation of the product (in each dose), and on the 7th day after the first dose. 2) A non-inferiority immunobridging study to extrapolate the efficacy of the Abdala vaccine in paediatric ages of 3-18 years, from immunogenicity results based on the evaluation of neutralizing antibodies (NAb) against SARS-CoV-2. The design followed basic principles for this type of analyses according WHO guidelines.

Key secondary outcomes:

1) Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time. 2) Inhibition to ACE2 (by ELISA - Enzyme-linked immunosorbent assay). Measurement time: at 42 (+3 days) with respect to baseline time. 3) SARS-CoV-2 viral neutralization response percentage (only 10% of those samples that have ≥ 30% inhibition at a 1/100 dilution will be evaluated in the RBD-ACE-2 binding neutralization assay ). Measurement time: at 42 (+3 days) with respect to baseline time.

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) Age between 3 and 18 years at the time of inclusion. 2) General physical examination and by appliances without alterations at the time of inclusion. 3) Nutritional assessment: weight / height ratio between 10 and 90 percentile (for children between 3 and 9 years of age). Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years old, according to the cut-off points for the Cuban pediatric population. 4) Voluntariness of both parents (or legal guardian) by signing the informed consent, as well as informed consent for adolescents aged ≥12 years.

Exclusion criteria:

1) History of SARS-CoV-2 infection or with this diagnosis at the time of inclusion in the study. 2) Contact or suspect of COVID-19 at the time of inclusion. 3) Body temperature ≥ 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours). 4) Acute infectious disease in the three days prior to the application of the vaccine. 5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 6) History of having received a vaccine against SARS-CoV-2 or against other coronaviruses. 7) Have received any other vaccine, in the 14 days prior to the administration of each dose. 8) Administration of any research product in the last 30 days or that its use is planned during the clinical trial. 9) Having been treated in the last 30 days or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study. 10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study. 11) Known hypersensitivity to thiomersal and to any of the components of the vaccine under study. 12) Tattoos in both deltoid regions that interfere with the injection site safety assessment. 13) History or suspicion of alcoholism or drug dependence. 14) Positive urine pregnancy test, before the administration of any of the three doses in women with biological capacity to have a pregnancy (history of menarche).

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:

Target sample size:

703

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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences; Doctor in medicine; First and second grade specialist in Hygiene and Epidemiology; Master in Clinical Trials; Master in Environmental Health; Titular Professor of the University of Medical Sciences of Havana; Principal researcher.

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:

+53-72716022

Email :

hernandez.bernal@cigb.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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

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:

+53-72716022

Email :

hernandez.bernal@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Surgical Medical Research Center (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

18/08/2021

Postal address of Ethic Committee :

Calle 216 y 11B, Playa, Havana, ZC: 6096, Cuba

Telephone:

+53-72718424

Email:

bcimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

02/11/2021

Date of available results:

11/08/2022

Date of first publication:

15/10/2023

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:

RPCEC00000390

Date of Registration in Primary Registry:

03/09/2021

Record Verification Date:

2024/05/29

Next update date:

2025/05/29

Link to the spanish version:

Click here

Registered Trials

Registration process

MEÑIQUE Study

About the RPCEC

Useful resources