SOBERANA CENTRO

Phase 2

• Conditions: COVID-19; SARS-CoV2; Disease Prevention; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; Healthy Volunteers

• Registration Number: RPCEC00000385
• Lead Sponsor: Finlay Vaccine Institute (IFV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-23
• Study Completion: 2022-12-30
• Results First Posted: 2023-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1166

Inclusion Criteria

1) Subjects aged between 19 and 80 years.
2) Subjects who give their informed consent to participate in the study in writing.
3) Women of childbearing age who use contraceptive methods during the study and are willing to use them up to three months after the corresponding vaccination schedule has concluded.

Exclusion Criteria

1) Subjects with acute febrile or infectious disease in the seven days prior to the administration of the vaccine or at the time of its application.
2) Subjects with diminished mental faculties for decision making.
3) Subjects with a history of known hypersensitivity to any of the components of the formulation.
4) Previous history of SARS-CoV-2 infection or subjects positive to the antigen test at the time of inclusion.
5) Subjects previously vaccinated against SARS-CoV-2.
6) Application of vaccines containing tetanus toxoid or the VA-MENGOC-BC vaccine in the last three months.
7) Application of any other vaccine of the extended immunization schedule in the last 30 days.
8) Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, HeberFERON, immunoferon, transfer factor, biomodulin T, any gamma globulin, levamisole, thymosin or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study.
9) Subjects with tattoos in the deltoid region on both arms.
10) Decompensated chronic diseases that limit vaccination according to criteria clinical.
11) Subjects with unstabilized malignant disease or who are receiving oncospecific treatment (cytostatics and / or radiotherapy) during the time of the study or have been receiving it in the last three months.
12) HIV positive subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.
13) Pregnancy, puerperium or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70.<br>Moreover, in a subset of subjects’ samples with seroconversion, the outcome will measure at months 4, 8 and 12 after completing scheme vaccination.