SOBERANA - INTERVENTIO

Not Applicable

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

• Registration Number: RPCEC00000360
• Lead Sponsor: Finlay Vaccine Institute (IFV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-19
• Study Completion: 2022-10-31
• Results First Posted: 2022-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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 as a result of medical questioning.
3. Allergy to any of the components of the vaccine.
4. Administration of immunomodulators in the 30 days prior to vaccination.
5. Decompensated chronic diseases that limit vaccination.
6. Pregnancy, childbirth and the puerperium.
7. Acute illness that contraindicates vaccination
8. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.
9. For the application of the booster dose, subject with a history of being convalescent of COVID, or having less than 5 months of the last dose applied.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the candidate's last dose.<br>2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the candidate's last dose.<br>3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the candidate's last dose.<br>4. Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose.<br>5. Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose.<br>6. Evaluate the immunogenicity of a dose of the vaccine candidate, in convalescent patients from COVID-19 with mild and moderate clinical symptoms and asymptomatic PCR positive.