Clinical trial NCT04944433: Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients
Official title: Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019 Vaccines
Renal Dialysis
Keywords: Seroepidemiologic Studies
Renal Dialysis
Coronavirus disease 2019 Vaccines
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Ministerio de Salud de Ciudad Autónoma de Buenos Aires
name: University of Buenos Aires
First posted: 2021-06-29
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients in an immunization plan with a COVID-19 vaccine from the hemodialysis centers of the Autonomous City of Buenos Aires

Brief summary: It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. Objectives: To evaluate the safety and efficacy of Coronavirus disease 2019 vaccines in hemodialysis patients.

Detailed description: Given the vulnerability of people with chronic kidney disease to Coronavirus 2019 , leading nephrology societies such as the National Kidney Federation and the American Kidney Foundation have issued statements calling for prioritization of these patients for vaccination. It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy.

Objectives:

1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
2. Determine the levels of Immunoglobulin G antibodies in patients who received a Coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization.

Methods Design: Multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a Coronavirus disease 2019 vaccine in the Autonomous City of Buenos Aires in a vaccination plan.

Analysis The proportion of patients with Adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. The immunoglobulin G titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using Generalized Estimating Equations models.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age on hemodialysis in an immunization plan with a Coronavirus disease 2019 vaccine.

Exclusion Criteria:

* Contraindication to receive the vaccine.

Primary outcomes:
measure: Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
timeFrame: one year
measure: To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Universidad de Buenos Aires Facultad de Medicina
state: Caba
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Guillermo IP Rosa Diez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Buenos Aires
name: Jorge SI Geffner
role: STUDY_CHAIR
affiliation: Sociedad Argentina de Nefrología
name: Fernando SI Lombi
role: STUDY_CHAIR
affiliation: Sociedad Argentina de Nefrología
name: Marina SI Papaginovic
role: STUDY_CHAIR
affiliation: Sociedad Argentina de Nefrología
name: Ricardo SI Heguilen
role: STUDY_CHAIR
affiliation: Sociedad Argentina de Nefrología
name: Luciana Fernandez SI Paganti
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Soledad SI Crucelegui
role: STUDY_CHAIR
affiliation: Hospital Italiano de Buenos Aires
name: Vanina SI Pagotto
role: STUDY_CHAIR
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