Revisions for BACONAO Study | Registro Público Cubano de Ensayos Clínicos

--- 16 November 2021 - 1:19pm by CIGB
+++ 19 July 2023 - 1:10pm by Gladys
-Matanzas, Tourism medical services where the vaccine will be applied.
+Matanzas, Cuban Medical Services where the vaccine will be applied to Tourism workers.
-Matanzas, “Mario Munnoz” military hospital
+Matanzas, Military Hospital "Mario Muñoz".
--11-15 00:00:00
+-11-22 00:00:00
-Specific anti-RBD IgG antibody titers of SARS-CoV-2 (geometric mean). Measurement time: on days 0 and 14 (+ 3 days).
+Difference in geometric means of SARS-CoV-2 anti-RBD IgG antibody titers (numerical value). Measurement time: on days 0 and 14 (+ 3 days).
-) Duration of the immune response after applying the full schedule of vaccination with Abdala (Time from end of complete scheme vaccination until booster dose). Measurement time: At baseline.
+) Anti-RBD IgG antibody titers of SARS-CoV-2 at the time of application of the corresponding booster dose (numerical value).  Measurement time: At baseline.
-) Response of inhibition of the interaction of RBD with its receptor ACE2 in a patient’s subset (by ELISA - Assay by enzyme-linked immunosorbent). Measurement time: on days 0 and 14 (+ 3 days).
+) Percentage of individuals with inhibition of the interaction of RBD with its ACE2 receptor ≥ 30% in a subgroup of individuals (by ELISA - Assay by enzyme-linked immunosorbent). Measurement time: on days 0 and 14 (+ 3 days).
 ) IgA antibody response in serum and nasal discharge in a patient’s subset (values according to sample type). Measurement time: on days 0 and 14 (+ 3 days).
 ) 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 (unrelated, doubtful, possible, probable, definitive), -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 sequels, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: At the next 30 minutes after the vaccine was applied and, after 14 days (with review of the ambulatory card of adverse events, in the possession of each participant).
 ) Subjects previously vaccinated with the full schedule (three doses) of Abdala.
-) At least three months after receiving the 3rd dose of Abdala.
+) Minimum of 5 and a half months after receiving the 3rd dose of Abdala.
 ) Voluntariness of the subject by signing the informed consent.
 ) Body temperature ≥ 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours).
 ) Acute infectious disease in the three days prior to the application of the vaccine.
-) Hypertension at the time of inclusion.
+) History of having received another vaccine against SARS-CoV-2 (different from Abdala).
-) History of having received another vaccine against SARS-CoV-2 (different from Abdala).
+) Known hypersensitivity to thiomersal and to any of the components of the formulation under study.
-) Known hypersensitivity to thiomersal and to any of the components of the formulation under study.
+) Pregnancy or lactation referred by the volunteer.
-) Pregnancy or lactation referred by the volunteer.
--12-15T00:00:00
+-12-22T00:00:00
-All subjects who meet selection criteria
+All subjects who meet selection criteria (1500-5000 subjects)
-/11/12
+/11/16
-/11/12
+/11/16

BACONAO 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:

Evaluation of the effect and safety of a booster dose of Mambisa or Abdala against COVID-19.

Secondary indentifying numbers:

IG/Mam-AbdI/CVD19/2106

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:

In process

Principal investigator

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

First name:

Roberto

Last name:

Cannete Villafranca

Medical Specialty :

Doctor of Medical Sciences; First and Second grade specialist in Microbiology; Master in Parasitology; Professor, Researcher and Full Academician.

Affiliation:

Matanzas University of Medical Sciences

Postal address:

Carretera Central Km 101

City:

Matanzas

Country:

Cuba

Zip Code:

40100

Telephone:

+53-45266414

Email address:

roberto.villafranca@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:

Matanzas, Cuban Medical Services where the vaccine will be applied to Tourism workers.

Matanzas, Military Hospital "Mario Muñoz".

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

22/11/2021

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

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

Group I, Abdala (Experimental): Abdala vaccine (RBD 50 µg + aluminum hydroxide 0.30 mg). It will be administered in a single dose by the intramuscular route: 0.5 mL in the deltoid region. Group II, Mambisa (Experimental): Mambisa vaccine candidate (CIGB-669): 200 µL (100 µL for each nostril, in a single dose) corresponding to 50 µg of recombinant RBD protein and 40 µg of AgnHB antigen.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Immunization, Secondary

Single Dose

Injections, Intramuscular

Administration, Intranasal

Intervention keyword:

ABDALA vaccine MAMBISA vaccine

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):

Difference in geometric means of SARS-CoV-2 anti-RBD IgG antibody titers (numerical value). Measurement time: on days 0 and 14 (+ 3 days).

Key secondary outcomes:

1) Anti-RBD IgG antibody titers of SARS-CoV-2 at the time of application of the corresponding booster dose (numerical value). Measurement time: At baseline. 2) Percentage of individuals with inhibition of the interaction of RBD with its ACE2 receptor ≥ 30% in a subgroup of individuals (by ELISA - Assay by enzyme-linked immunosorbent). Measurement time: on days 0 and 14 (+ 3 days). 3) IgA antibody response in serum and nasal discharge in a patient’s subset (values according to sample type). Measurement time: on days 0 and 14 (+ 3 days). 4) 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 (unrelated, doubtful, possible, probable, definitive), -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 sequels, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: At the next 30 minutes after the vaccine was applied and, after 14 days (with review of the ambulatory card of adverse events, in the possession of each participant).

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 previously vaccinated with the full schedule (three doses) of Abdala. 2) Minimum of 5 and a half months after receiving the 3rd dose of Abdala. 3) Voluntariness of the subject by signing the informed consent.

Exclusion criteria:

1) History of SARS-CoV-2 infection or suspected COVID-19 at the time of inclusion. 2) Body temperature ≥ 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours). 3) Acute infectious disease in the three days prior to the application of the vaccine. 4) History of having received another vaccine against SARS-CoV-2 (different from Abdala). 5) Known hypersensitivity to thiomersal and to any of the components of the formulation under study. 6) Pregnancy or lactation referred by the volunteer.

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:

Target sample size:

All subjects who meet selection criteria (1500-5000 subjects)

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; First and Second grade specialist in Hygiene and Epidemiology; Full Professor and Senior Researcher.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havama

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:

Doctor of Medical Sciences; First and Second grade specialist in Hygiene and Epidemiology; Full Professor and Senior 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

Research Ethics Committees

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

Name of Research Ethics Committees:

Matanzas University of Medical Sciences

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

08/11/2021

Postal address of Ethic Committee :

Carretera central Km 101, Matanzas, ZC: 40100, Cuba

Telephone:

+53-45266414

Email:

rector.mtz@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

22/12/2021

Date of available results:

31/01/2022

Date of first publication:

15/03/2022

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:

RPCEC00000398

Date of Registration in Primary Registry:

12/11/2021

Record Verification Date:

2021/11/16

Next update date:

2022/11/16

Link to the spanish version:

Click here

Registered Trials

Registration process

BACONAO Study

About the RPCEC

Useful resources