Revisions for ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos

--- 27 March 2021 - 7:55pm by Gladys
+++ 8 April 2021 - 4:21pm by lazara
-/03/27
+/04/08
-/03/27
+/04/08

Revision of 8 April 2021 - 4:21pm:

ABDALA-Intervention

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:

“STUDY OF POPULATION INTERVENTION WITH VACCINAL CANDIDATE ABDALA TO EVALUATE DIRECT AND INDIRECT EFFECTS OF VACCINATION ON COHORT RISKS OF INFECTION BY SARS CoV-2” (COVID-19)

Secondary indentifying numbers:

IG/CIGB-66/IM/CVD19/2104

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP); Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

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:

Sonia

Last name:

Resik Aguirre

Medical Specialty :

Doctor in medicine. Second degree specialist in Microbiology. Doctor of Medical Sciences. Doctor of Science. Master in Virology. Senior Researcher. Titular teacher.

Affiliation:

Institute of Tropical Medicine "Pedro Kouri" (IPK)

Postal address:

Avenida Novia del Mediodia, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email address:

sresik@ipk.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:

Havana, Pharmaceutical Laboratories AICA

Havana, National Center for the Production of Laboratory Animals (CENPALAB)

Havana, Educational Polyclinic “26 de julio“

Havana, Immunoassay Center (CIE)

Havana, Medical and Surgical Research Center (CIMEQ)

Havana, National Center for Scientific Research (CNIC)

Havana, Pharmaceutical Laboratories “Roberto Escudero”

Havana, Military Hospital "Dr. Luis Diaz Soto"

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

29/03/2021

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):

Vaccine candidate CIGB-66 (RBD 50 µg + Aluminum hydroxide 0,30 mg)/0,5 mL by intramuscular route, in the deltoid región, schedule 0-14-28 days.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

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. Virologically confirmed symptomatic infection of Covid-19 (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 2. Confirmed Covid-19 infection with signs of severe systemic disease (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 3. Confirmed SARS-Cov-2 infection from routine surveillance (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 4. Death from causes directly attributable to a complication of COVID-19 (Yes No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 5. Global burden of incidence: Cumulative incidence of cases in the observation period. Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months.

Key secondary outcomes:

1. Virologically confirmed COVID-19 disease. Measurement time: during vaccination intervals and up to 28 days after the third dose. 2. Confirmed COVID-19 disease evolving toward severity. Measurement time: during vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 3. Confirmed COVID-19 disease evolving to Death from a cause directly attributable to a COVID-19 complication. Measurement time: during the vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 4. Virologically confirmed asymptomatic SARS-Cov-2 infection detected during a surveillance action. Measurement time: during vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 5. Proportion of subjects hospitalized for confirmed COVID-19 disease. Measurement time: from 14 days after the administration of the first dose of CIGB-66, and for 4 months. 6. Adverse Events-AE (Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Seriousness of adverse events (Serious, Not serious), -Causality relationship (causal association consistent with vaccination, Indeterminate, Inconsistent causal association with vaccination, not classifiable), - Result (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: 1 hour after the administration of each dose, 14 days after the administration of the 1st and the 2nd dose, respectively, and up to 28 days after the 3rd dose of the vaccine candidate.

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. Subjects of both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate.

Exclusion criteria:

1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection by medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunosuppressants in the 30 days prior to vaccination 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, puerperium and lactation. 7. Acute illness that contraindicates vaccination. 8. HIV positive subject with detectable viral load, opportunistic disease or CD4 + count less than 200 copies (according to the last follow-up check of the patient).

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:

124000

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:

Sonia

Last Name:

Resik Aguirre

Specialty:

Doctor in medicine. Second degree specialist in Microbiology. Doctor of Medical Sciences. Doctor of Science. Master in Virology. Senior Researcher. Titular teacher.

Affiliation:

Institute of Tropical Medicine "Pedro Kouri" (IPK)

Postal Address:

Avenida Novia del Mediodia, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email :

sresik@ipk.sld.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:

Pablo

Last Name:

Diaz Reyes

Specialty:

Doctor in medicine. First Degree Specialist in Neonatology. Vaccine Specialist.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB). Clinical Research Department.

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72080428 ext 145

Email :

pablo.dias@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Ad hoc Centralized Research Ethics Committee for COVID-19 vaccines

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

26/03/2021

Postal address of Ethic Committee :

Manuel Fajardo Faculty of Medical Sciences. Calle D e/ Zapata y 29, ZC. 10400 Vedado, Havana, Cuba

Telephone:

+53-78330171

Email:

orleliebre@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/09/2021

Date of available results:

30/12/2021

Date of first publication:

14/02/2022

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:

RPCEC00000363

Date of Registration in Primary Registry:

27/03/2021

Record Verification Date:

2021/04/08

Next update date:

2022/04/08

Link to the spanish version:

Click here

Registered Trials

Registration process

ABDALA-Intervention

About the RPCEC

Useful resources