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:
Immunogenicity evaluation of the heterologous combination of two doses of SINOPHARM and one dose of SOBERANA Plus: a post-authorization study for emergency use (COVID-19)
Acronym of Scientific Title:
Sinopharm-SOBERANA COVID-Cienfuegos
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
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.
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
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:
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
Date of first enrollment:
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:
Health condition(s) code:
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
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.
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
Study design Section to complete information about the characteristics of the study design.
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
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
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.
Postal Address:
21 avenue bw/ 198 and 200 Atabey, Playa
Data Sharing Section to complete the data related to the data sharing plan.
Description of Data Sharing Plan:
The immunological individual data, and other supporting clinical documents will be available after publication and requesting.
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 date of Ethic Committee:
Postal address of Ethic Committee :
Calle 51 A y Avenida 5 de Septiembre, Cienfuegos, Cuba. CP 55110
About study completion Section to complete the data related to the study completion.
Results Study Section to complete the data related to the summarized results.
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
