To evaluate the immunogenicity and safety of SOBERANA® 02 and SOBERANA® Plus as booster of immunity against the omicrom variant of SARS-CoV-2, in adult subjects

Not Applicable

• Conditions: COVID-19; Infecciones Respiratorias; Infecciones del Sistema Respiratorio; Enfermedades Pulmonares; Neumonía; Neumonía viral; Infecciones; Infecciones por Nidovirales; Infecciones por Coronavirus; Infecciones por Coronaviridae

• Registration Number: RPCEC00000424
• Lead Sponsor: Finlay Institute of Vaccines (IFV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Study Completion: 2024-06-29
• Last Update Posted: 19 August 2024
• Results First Posted: 2024-11-17

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

1. Subjects of both sexes, over 18 years of age.
2. Subjects who give their informed consent to participate in the study.
3. Subjects who received the primary vaccination schedule against SARS-CoV-2 or convalescent subjects from COVID-19 in a period greater than or equal to 6 months.

Exclusion Criteria

1. Subjects with febrile or acute infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.
2. Subjects with chronic diseases NOT controlled, according to clinical criteria.
3. Subjects with a history of severe allergy (anaphylactic shock, angioneurotic edema, edema of the glottis, severe urticaria) to SOBERANA® 02 and SOBERANA® Plus vaccines.
4. Subjects convalescent from COVID-19 in a period of less than 6 months.
5. Having received a booster dose against SARS-CoV-2 in less than 6 months.
6. Application of another vaccine in the last 30 days.
7. Previous vaccination with tetanus toxoid vaccine in a period of less than 6 months.
8. History of having received a transfusion of blood or blood products in the last 3 months.
9. Women of childbearing age with a history of amenorrhea greater than 4 weeks or pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eutralizing antibody titers: Viral neutralization assay. Measurement time: 0, 28 days, 6 months and one year