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OpenTrials
Completed

NCT Number: NCT04843917

Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects receiving any COVID-19 vaccine.

Exclusion criteria

  • Subjects who do not agree to participate

Treatment and study plan

Immunoglobulin G detection

Diagnostic Test

Detection of immunoglobulin G against Spike Receptor Binding Domain against severe acute respiratory syndrome coronavirus 2

Primary outcomes

  1. 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

    Time frame: 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

  2. To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19

    Time frame: 1 year

    To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Immunity Against the COVID-19 Vaccine in Healthcare Workers of Buenos Aires, Argentine.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2021
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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