Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine

Completed

• Conditions: Coronavirus 2019; Vaccine; Healthcare Workers

• Registration Number: NCT04843917
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine.

Detailed Description

Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. The Ministry of Health of the Nation, designed the "Strategic Plan for vaccination", which the first line being the health workers " The National Administration of Medicines, Food and Medical Technology authorized two emergency vaccines for administration, Sputnik V and Sinopharm vaccine. It is important to evaluate immunogenicity and its correlation with the long-term efficacy and safety profile of this vaccines.

Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine between the time before the first dose, and after 1 month, 6 months and 12 months after the completion of the immunization, depending on whether they have received the Sputnik V vaccine or the Sinopharm vaccine, and correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19 Methodology: Design: observational and analytical study of a prospective cohort of healthcare workers immunized with some COVID-19 vaccine. The presence of IgG will be determined qualitatively and quantitatively. The immunoglobulin G titer in each period will be compared globally and according to the type of vaccine administered.

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-14
• Primary Completion: 2023-06-09
• Study Completion: 2023-08-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects receiving any COVID-19 vaccine.

Exclusion Criteria

• Subjects who do not agree to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine	1 year	To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine
To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19	1 year	To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Caba, Argentina