Clinical trial NCT04843917: Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine
Official title: Immunity Against the COVID-19 Vaccine in Healthcare Workers of Buenos Aires, Argentine.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus 2019
Healthcare Workers
Vaccine
Keywords: COVID-19 Vaccines
Health Personnel
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers who want to receive any COVID-19 vaccine

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.

Eligibility criteria: Inclusion Criteria:

* Subjects receiving any COVID-19 vaccine.

Exclusion Criteria:

* Subjects who do not agree to participate

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Caba
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: vanina Pagotto, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Silvana Figar, MSC
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Hernán Garcia Rivello, Pharm
role: STUDY_DIRECTOR
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