Revisions for Sinopharm-SOBERANA COVID-Cienfuegos | Registro Público Cubano de Ensayos Clínicos

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Revision of 30 August 2022 - 1:56pm:

Sinopharm-SOBERANA COVID-Cienfuegos

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:

Vac-COVID-Cienfuegos

Scientific title:

Immunogenicity evaluation of the heterologous combination of two doses of SINOPHARM and one dose of SOBERANA Plus: a post-authorization study for emergency use.

Acronym of Scientific Title:

Sinopharm-SOBERANA COVID-Cienfuegos

Secondary indentifying numbers:

Not Applicable

Issuing authority of the secondary identifying numbers:

Not Applicable

Source(s) of monetary or material support:

Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) of the Ministry of Science, Technology and Environment, Ministry of Public Health.

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:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

First degree specialist in Epidemiology

Affiliation:

"Pedro Kouri" Institute of Tropical Medicine

Postal address:

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

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020427

Email address:

mariaeugenia@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:

Cienfuegos, Palmira. Manuel Piti Fajardo Polyclinic. Laydami Cardenas Gonzalez, MD. First Degree Specialist in Integral General Medicine

Cienfuegos, Cruces. Manuel Piti Fajardo Polyclinic. Belkys Elena Morales Hernandez, MD. First Degree Specialist in Integral General Medicine

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

14/09/2021

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:

COVID-19

SARS-CoV-2

Intervention(s):

Vaccine SINOPHARM (6.5 U/dose of antigens from the inactivated virus SARS-CoV-2), Intramuscular (IM), 0.5 mL, 0 – 21 days + vaccine SOBERANA Plus (50 µg of d-RBD+ Gel of alumine hydroxide, IM, 0.5 mL) as heterologous dose day 42.

Intervention code:

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Intervention keyword:

SOBERANA Plus SINOPHARM

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):

Concentration of specific anti-RBD IgG antibodies. Measurement time: Day 42, 63

Key secondary outcomes:

% ACE2-RBD inhibition: Measurement time: Day 42, 63 Neutralizing antibody titer: Measurement time: Day 42, 63 (sample subset).

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 with 19 years or more, who were eligible for vaccination with SINOPHARM and SOBERANA Plus in the province of Cienfuegos. 2.- Subjects who give informed consent for blood extraction at the scheduled times.

Exclusion criteria:

1.- Pregnancy, puerperium or lactation. 2.- Subjects with a history of having suffered from COVID-19

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:

202

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:

Maria

Middle Name:

Eugenia

Last Name:

Toledo Romani

Specialty:

First degree specialist in Epidemiology

Affiliation:

"Pedro Kouri" Institute of Tropical Medicine

Postal Address:

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

City:

La Habana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020425

Email :

mariaeugenia@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:

Yanet

Last Name:

Climent Ruiz

Specialty:

MD Biology Sciences

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 avenue bw/ 198 and 200 Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72718331

Email :

ycliment@finlay.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Faculty of Medical Sciences of the Cienfuegos Province

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/08/2021

Postal address of Ethic Committee :

Calle 51 A y Avenida 5 de Septiembre, Cienfuegos, Cuba. CP 55110

Telephone:

+53-43500600

Email:

rector@ucm.cfg.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

202

Study completion date:

20/12/2021

Date of available results:

16/08/2022

Date of first publication:

25/08/2022

Results Study

Section to complete the data related to the summarized results.

Results file:

Final Sinopharm+Plus para RPCEC inglés.pdf

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:

RPCEC00000408

Date of Registration in Primary Registry:

30/08/2022

Record Verification Date:

2022/08/30

Next update date:

2023/08/30

Link to the spanish version:

Click here

Registered Trials

Registration process

Sinopharm-SOBERANA COVID-Cienfuegos

About the RPCEC

Useful resources