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

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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:

BACONAO-II

Scientific title:

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

Secondary indentifying numbers:

IG/AbdI/CVD19/2407

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Marjoris

Last name:

Pinnera Martinez

Medical Specialty :

Second-degree specialist in Internal Medicine; Second-degree specialist in Intensive and Emergency Medicine.

Affiliation:

Teaching Clinical Surgical Provincial Hospital “Saturnino Lora”

Postal address:

Ave Libertadores e/ 4ta y 6ta

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90100

Telephone:

+53-22629509

Email address:

marjoris.p@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:

Pending

Date of first enrollment:

09/09/2024

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

Intervention(s):

Abdala group (Experimental): All subjects included will receive the 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. For the analysis of the results, patients will be divided into two groups as follows: Group A: subjects who received the full three-dose regimen (primary vaccination) + booster dose with the Abdala vaccine against COVID-19. Group B: subjects who received primary vaccination with Soberana 02/plus + booster dose (with Soberana or 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):

Geometric mean difference of SARS-CoV-2 anti-RBD IgG antibody titers (numerical value). Time of measurement: on days 0 and 21 (±2 days).

Key secondary outcomes:

1) SARS-CoV-2 anti-RBD IgG antibody titers at the time of booster dose administration (numerical value). Time of measurement: at baseline. 2) Percentage of individuals with inhibition of the interaction of the RBD with its ACE2 receptor ≥ 30% (by ELISA - Enzyme-linked immunosorbent assay). Time of measurement: on days 0 and 21 (±2 days). 3) Percentage and magnitude of viral neutralization response (Abdala neutralization capacity against different SARS-CoV-2 variants (KP.2, KP.3, BA.2.86, EG.5, JN.1, delta) in a subset of individuals. Measurement time: on days 0 and 21 (±2 days). 4) Clinical Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Outcome (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: within 20 minutes of vaccination and 21 days later (with review of the outpatient adverse event card, held by 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:

60 years

Inclusion criteria:

1) Individuals between the ages of 19 and 60. 2) Subjects who have received: a) primary vaccination and booster with Abdala or b) primary vaccination with Soberana (02/plus) and booster dose (with Soberana or Abdala). 3) At least 8 months after receiving the last booster of the anti-COVID-19 vaccine. 4) Voluntary nature of the subject by signing the informed consent.

Exclusion criteria:

1) Acute infectious disease in the three days prior to vaccine administration. 2) Uncontrolled chronic disease at the time of inclusion. 3) Known hypersensitivity to thiomersal and any of the components of the formulation under 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

NA

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 Degree Specialist in Hygiene and Epidemiology; Full Professor; Full Researcher; Full Academician.

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; First and Second Degree Specialist in Hygiene and Epidemiology; Full Professor; Full Researcher; Full Academician.

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:

Teaching Clinical Surgical Provincial Hospital “Saturnino Lora”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

29/08/2024

Postal address of Ethic Committee :

Ave Libertadores e/ 4ta y 6ta. Santiago de Cuba. ZC: 90100. Cuba

Telephone:

+53-58249457

Email:

dirgneralhpsl@in fomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

11/10/2024

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:

RPCEC00000450

Date of Registration in Primary Registry:

06/09/2024

Record Verification Date:

2024/09/06

Next update date:

2025/09/06

Link to the spanish version:

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

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