Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04843917
Collaborator
(none)
100
1
28
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Immunoglobulin G detection

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immunity Against the COVID-19 Vaccine in Healthcare Workers of Buenos Aires, Argentine.
Actual Study Start Date :
Apr 9, 2021
Anticipated Primary Completion Date :
Jun 9, 2023
Anticipated Study Completion Date :
Aug 9, 2023

Outcome Measures

Primary Outcome Measures

  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 [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 [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Subjects receiving any COVID-19 vaccine.
Exclusion Criteria:
  • Subjects who do not agree to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Italiano de Buenos Aires Buenos Aires Caba Argentina C1199ABB

Sponsors and Collaborators

  • Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: vanina Pagotto, MSC, Hospital Italiano de Buenos Aires
  • Study Chair: Silvana Figar, MSC, Hospital Italiano de Buenos Aires
  • Study Director: HernĂ¡n Garcia Rivello, Pharm, Hospital Italiano de Buenos Aires

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
VANINA LAURA PAGOTTO, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT04843917
Other Study ID Numbers:
  • 3913
First Posted:
Apr 14, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by VANINA LAURA PAGOTTO, Principal Investigator, Hospital Italiano de Buenos Aires
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022