ABDALA Clinical 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 safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

Secondary indentifying numbers:

IG/CIGB-66I/CVD19/2002

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:

Maria

Midle name:

del Carmen

Last name:

Ricardo Cobas

Medical Specialty :

1st degree specialist in Internal Medicine and 2nd degree specialist in Intensive and Emergency Medicine, Master in Infectious Diseases.

Affiliation:

"Saturnino Lora" Provincial Hospital

Postal address:

Avenida de los Libertadores

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90100

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:

Pending

Date of first enrollment:

07/12/2020

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: CIGB-66 (RBD 25 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule). Group 2: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule). Group 3: Placebo; 0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule). Group 4: CIGB-66 (RBD 25 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days). Group 5: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days). Group 6: Placebo; 0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days). These interventions will be carried out during the first stage (phase I). Subsequently, an intermediate analysis will be carried out where doses and immunization schedules for phase II will be defined.

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):

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), -Causality relationship (no related, 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 sequelae, 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), at 24, 48 and 72 hours, and on the 7th day. 2. Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: on days 28 and 42 (for the short scheme 0-14-28) and 28, 56 and 70 (for the long scheme 0-28-56), with respect to the baseline time.

Key secondary outcomes:

1. Specific anti-RBD IgG antibodies (geometric mean). Measurement time: on days 0, 28 and 42 (for the short vaccination schedule: 0-14-28) and 0, 28, 56 and 70 (for the long schedule: 0-28-56). 2. ACE2 inhibition (by ELISA - Enzyme-linked immunoadsorption assay). Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 3. Humoral response of specific anti-RBD IgM antibodies. Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme).

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:

54 years

Inclusion criteria:

1) Individuals aged between 19 and 54 years, both inclusive (for phase I) and between 19 and 80 years old, both inclusive (for phase II). 2) Physical examination without significant alterations. 3) Hematological and blood chemistry determinations within or outside normal ranges, without clinical relevance (only for phase I). 4) Voluntariness of the subject by signing the informed consent.

Exclusion criteria:

1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2. 2) Contact or suspect of COVID-19 at the time of inclusion. 3) Subjects at high risk of exposure to SARS-CoV-2 infection (contacts of confirmed cases, health workers in the 1st line of medical care [Emergency, ICU, other risk areas]). 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 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 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:

Factorial

Phase:

1-2

Target sample size:

132 (for the first stage - phase I)

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; 1st and 2nd 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

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; 1st and 2nd 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:

“Saturnino Lora" Provincial Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

16/11/2020

Postal address of Ethic Committee :

Avenida de los Libertadores, Santiago de Cuba, ZC: 90100, Cuba

Telephone:

-

Email:

-

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/05/2021

Date of available results:

30/06/2021

Date of first publication:

30/07/2021

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:

RPCEC00000346

Date of Registration in Primary Registry:

26/11/2020

Record Verification Date:

2020/11/27

Next update date:

2021/11/27

Link to the spanish version:

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ABDALA Clinical Study

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