ABDALA Clinical Study - Phase III | Registro Público Cubano de Ensayos Clínicos

ABDALA Clinical Study - Phase III

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:

Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial for the evaluation in adults of the efficacy, safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

Secondary indentifying numbers:

IG/CIGB-66I/CVD19/2103

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)

Authorization date :

19/03/2021

Reference number:

133/05.004.21BA

Principal investigator

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

First name:

Maria

Midle name:

del Carmen

Last name:

Ricardo Cobas

Medical Specialty :

1st degree specialist in Internal Medicine and 2nd degree in Intensive and Emergency Medicine; Master in Medical Emergencies and Primary Health Care; Assistant Professor.

Affiliation:

"Saturnino Lora" Provincial Hospital

Postal address:

Avenida de los Libertadores

City:

Santiago de Cuba

País:

Cuba

Zip Code:

90100

Telephone:

+53-59934960

Email address:

maria.ricardo@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:

Santiago de Cuba, “Jose Marti” Polyclinic, Tamara Machado Herrera, 1st grade specialist in MGI.

Santiago de Cuba, “Frank Pais” Polyclinic, Zenaida Escalona Penna, 1st grade specialist in MGI.

Santiago de Cuba, “Carlos J. Finlay” Polyclinic, Francisco Pasto Rivero, 1st grade specialist in MGI.

Santiago de Cuba, “Camilo Torres” Polyclinic, Angel Luis Cascaret Santiago, 1st grade specialist in MGI.

Santiago de Cuba, “Ramon Lopez Penna” Polyclinic, Magda Matos Fonseca, 1st grade specialist in MGI.

Santiago de Cuba, “28 de septiembre” Polyclinic, Yuneisi Larrea Conte, 1st grade specialist in MGI.

Santiago de Cuba, “30 de noviembre” Polyclinic, Yamila Alcolea Leon, 1st grade specialist in MGI.

Santiago de Cuba, “Josue Pais” Polyclinic, Delia Moraguez Rodriguez, 1st grade specialist in MGI.

Santiago de Cuba, “Mario Munnoz” Polyclinic, Ariadna Mesa Yañez, 1st grade specialist in MGI.

Santiago de Cuba, “Ernesto Guevara” Polyclinic, Radisleidis Montoya Aranda, 1st grade specialist in MGI.

Santiago de Cuba, “Luis Ramirez” Polyclinic, Yunailis Blanco Garrido, 1st grade specialist in MGI.

Santiago de Cuba, “Julian Grimau” Polyclinic, Jalimy Soler Diaz, 1st grade specialist in MGI.

Santiago de Cuba, "Armando Garcia” Polyclinic, Vivian Maritza Velazquez, 1st grade specialist in MGI.

Guantanamo, “Emilio Daudinot” Polyclinic, Manuel Batista Columbie, 1st grade specialist in MGI.

Guantanamo, “Omar Ranedo” Polyclinic, Nilva Rodriguez Guilarte, 1st grade specialist in MGI.

Guantanamo, “Asdrubal Lopez” Polyclinic, Maria del Carmen Martinez Rodriguez, 1st grade specialist in MGI.

Guantanamo, “Martires del 4 de agosto” Polyclinic, Eradis Payam Romero, 1st grade specialist in MGI.

Guantanamo, “4 de abril” Polyclinic, Ayanis Reyes Pacheco, 1st grade specialist in MGI.

Granma, Specialties Outpatient Consultation, Reynel Marron Gonzalez, 2nd degree Specialist in Immunology.

Santiago de Cuba, "Joaquin Castillo Duany" Military Hospital, Sandra Caridad Laurencio Vallina, 2nd degree specialist in MGI.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

22/03/2021

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):

Group 1 (Experimental): CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days). Group 2 (Control): Placebo; 0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days).

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Placebos

Injections, Intramuscular

Intervention keyword:

CIGB-66

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):

Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product.

Key secondary outcomes:

1) Prevention of mild, moderate and severe forms of COVID-19 (number of symptomatic COVID-19 subjects according to intensity and evolution): Measurement time: from 14 days after the 3rd dose of the research product. 2) Prevention of asymptomatic cases in individuals confirmed by SARS-Co-V-2 PCR (number of SARS-CoV-2 PCR-positive subjects evolving asymptomatically). Measurement time: from 14 days after the 3rd dose of the research product. 3) 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), -Causality relationship (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: before the administration of each dose of the research product, in the first hour after inoculation of the product (in each dose), and in the first 72 hours in active research in the community. 4) Proportion of subjects with seroconversion of SARS-CoV-2 anti-RBD IgG antibodies (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: at 56 ± 5 days with respect to baseline time. 5) Specific anti-RBD IgG antibodies (geometric mean). Measurement time: at 56 ± 5 days with respect to baseline time. 6) Inhibition to ACE2 (by ELISA - Enzyme Linked Immunoadsorption Assay). Measurement time: at 56 ± 5 days with respect to baseline time. 7) SARS-CoV-2 viral neutralization response percentage (only those samples that have ≥ 50% inhibition at a 1/100 dilution in the RBD-ACE-2 binding neutralization assay will be evaluated). Measurement time: at 56 ± 5 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:

19 years

Maximum age:

80 years

Inclusion criteria:

1) Individuals aged between 19 and 80 years 2) Physical examination without significant alterations. 3) Voluntariness of the subject by signing the informed consent.

Exclusion criteria:

1) Subjects with a history of SARS-CoV-2 infection confirmed by RT-PCR or with this virological diagnosis at the time of inclusion in the study. 2) Convalescent, contact or suspect of COVID-19 at the time of inclusion. 3) Subjects who have received a vaccine candidate against COVID-19. 4) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia. 5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 6) Body mass index ≤18 or ≥ 35 Kg / m2. 7) Subjects with tattoos in both deltoid regions. 8) Administration of any research product in the last three months. 9) Subject treated in the last three months 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 formulation under study. 12) History or suspicion of alcoholism or drug dependence. 13) Pregnancy or breastfeeding. Woman of reproductive age not using contraceptives or planning pregnancy. 14) Obvious mental incapacity to issue consent and act accordingly with the study.

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 controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

48290

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; 1st and 2nd 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

País:

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

País:

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:

Research Ethics Committee Centralized Ad hoc

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

16/03/2021

Postal address of Ethic Committee :

“Saturnino Lora" Provincial Hospital. Avenida de los Libertadores, Santiago de Cuba, ZC: 90100, Cuba

Telephone:

Correo electrónico:

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

25/06/2021

Date of available results:

10/07/2021

Date of first publication:

30/04/2022

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:

RPCEC00000359

Date of Registration in Primary Registry:

18/03/2021

Record Verification Date:

2022/04/04

Next update date:

2023/04/04

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