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Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine

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ClinicalTrials.gov Identifier: NCT04843917
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
VANINA LAURA PAGOTTO, 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.

Condition or disease Intervention/treatment
Coronavirus 2019 Healthcare Workers Vaccine 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.

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Study Type : Observational
Estimated 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 : April 9, 2021
Estimated Primary Completion Date : June 9, 2022
Estimated Study Completion Date : August 9, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Immunoglobulin G detection
    Detection of immunoglobulin G against Spike Receptor Binding Domain against severe acute respiratory syndrome coronavirus 2


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 [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health care workers who want to receive any COVID-19 vaccine
Criteria

Inclusion Criteria:

  • Subjects receiving any COVID-19 vaccine.

Exclusion Criteria:

  • Subjects who do not agree to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843917


Contacts
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Contact: vanina Pagotto, MSC 54 1149590200 ext 9353 vanina.pagotto@hospitalitaliano.org.ar
Contact: Silvana Figar, MSC 54 11 49590200 ext 9353 silvana.figar@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Caba, Argentina, C1199ABB
Contact: Vanina L Pagotto, MD MG    0054 49590200 ext 5398    vanina.pagotto@hospitalitaliano.or.ar   
Contact: Silvana Figar, MD MG    0054 49590200 ext 5398    silvana.figar@hospitalitaliano.org.ar   
Sub-Investigator: Hernán García Rivello         
Sub-Investigator: Diego Arrigo         
Sub-Investigator: Hernán Michelángelo         
Sub-Investigator: María Inés Staneloni         
Sub-Investigator: Analía Ferloni         
Sub-Investigator: Valeria Asprea         
Sub-Investigator: Valeria Aliperti         
Sub-Investigator: Victoria Ardiles         
Sub-Investigator: Silvana Figar         
Sub-Investigator: Diego Giunta         
Principal Investigator: Vanina Pagotto         
Sub-Investigator: Facundo Seoane         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: vanina Pagotto, MSC Hospital Italiano de Buenos Aires
Study Chair: Silvana Figar, MSC Hospital Italiano de Buenos Aires
Study Director: Hernán Garcia Rivello, Pharm Hospital Italiano de Buenos Aires
Additional Information:
Publications of Results:
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.

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Responsible Party: VANINA LAURA PAGOTTO, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04843917    
Other Study ID Numbers: 3913
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VANINA LAURA PAGOTTO, Hospital Italiano de Buenos Aires:
COVID-19 Vaccines
Health Personnel
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs