SOBERANA 02-FaseIII

Phase 3

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

• Registration Number: RPCEC00000354
• Lead Sponsor: Finlay Vaccine Institute (IFV)

Brief Summary

SAFETY RESULTS: The vaccine candidate was generally found to be safe and well tolerated. There was a predominance of local events, with pain being the most frequent, the events generally lasting between 1 to 3 days and the frequency of their appearance decreased in the second and third injections. EFFICACY RESULTS: The per-protocol population efficacy analysis of the FINLAY-FR-2 vaccine candidate based on a randomized, blinded, placebo-controlled trial that included 42,511 subjects from the total study population (44,031), shows a overall efficacy for the prevention of symptomatic disease of 69.7% (95% CI 56.5-78.9) for the two-dose scheme; 92.0% (95% CI 80.4–96.7%) for the three-dose heterologous schedule, considering the analysis performed with respect to the Placebo group from 14 days after completion of the 2-dose vaccination schedule (for the efficacy analysis of 2 dose) and from 42 days after completion of the 2-dose vaccination schedule (for the placebo group in the 3-dose efficacy analysis) to ensure concurrent comparison. Efficacy estimation was also performed according to the analysis originally planned in the protocol, in which the placebo observation period started from 14 days after the 2nd dose (for the efficacy of both schemes) so it was not exactly concurrent with the observation period of the 3-dose schedule. The estimate based on this planned analysis shows that the efficacy of the 2-dose schedule is 70.7% (95% CI: 58.8; 79.1) and 92.4% (95% CI: 86.9-95.6) for the 3-dose schedule. Additionally, and before the appearance of intercurrent events, efficacy was estimated using a synthetic placebo group (based on the incidence of the municipalities where the CT was performed) and this estimate was consistent with the demonstrated clinical efficacy. Efficacy in preventing severe disease is 74.9% (95% CI 33.7-90.5) for the two-dose schedule of the FINLAY-FR-2 candidate, and 63.6% for avoiding hospitalization in intensive care units. In both cases, the efficacy is 100% after completion of the 3-dose heterologous regimen.<br><br>CONCLUSIONS: This report shows that the FINLAY-FR-2 vaccine candidate was safe and well tolerated, the most frequent adverse event was local pain. The FINLAY-FR-2 vaccine candidate in a two-dose schedule achieved a clinical efficacy of 69.7% in the prevention of symptomatic disease, which increases to 92.0% when the third heterologous dose with FINLAY-FR1A is administered. In both schemes, the efficacy in the prevention of symptomatic disease is higher than what was proposed in the study hypothesis (60%) and the 50% established as the minimum criterion according to the World Health Organization (7) to validate its emergency use in the current COVID-19 pandemic.<br><br>

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Study Completion: 2022-01-15
• Results First Posted: 2022-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44010

Inclusion Criteria

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

Exclusion Criteria

1. Subjects with acute febrile or infectious disease in the 7 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 hypersensitivity to thiomersal or to some of the components of the formulation.
4. Previous or current history of SARS-CoV-2 infection (questioning)
5. Application of vaccines containing tetanus toxoid in the last 3 months.
6. Subjects previously vaccinated against SARS-CoV-2.
7. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, Biomodulin T, any gamma globulin, Levamisole, Heberferon, 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.
8. Pregnancy, puerperium or lactation.
9. Subjects with tattoos in the deltoid region on both arms.
10. Decompensated chronic diseases that limit vaccination according to clinical criteria.
11. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.
12. Subjects with unstabilized malignant disease or who are receiving cytostatic treatment and / or radiotherapy during the time of the study or have been receiving it in the last three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation.