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NCT04944433 Clinical Trial

Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

Renal Dialysis Clinical Trial

Official title:
Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04944433
Other study ID # 7412
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2021
Est. completion date August 4, 2022

Study information
Verified date August 2022
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 950
Est. completion date August 4, 2022
Est. primary completion date August 4, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Universidad de Buenos Aires Facultad de Medicina Buenos Aires Caba

Sponsors (3)
Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires Ministerio de Salud de Ciudad Autónoma de Buenos Aires, University of Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (10)

Di Pasquale A, Bonanni P, Garçon N, Stanberry LR, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: Practical aspects in assessing benefits and risks. Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8. Re — View Citation

Heldman MR, Limaye AP. SARS-CoV-2 Vaccines in Kidney Transplant Recipients: Will They Be Safe and Effective and How Will We Know? J Am Soc Nephrol. 2021 May 3;32(5):1021-1024. doi: 10.1681/ASN.2021010023. Epub 2021 Mar 24. — View Citation

Hervé C, Laupèze B, Del Giudice G, Didierlaurent AM, Tavares Da Silva F. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4:39. doi: 10.1038/s41541-019-0132-6. eCollection 2019. Review. — View Citation

Labriola L, Scohy A, Seghers F, Perlot Q, De Greef J, Desmet C, Romain C, Morelle J, Yombi JC, Kabamba B, Rodriguez-Villalobos H, Jadoul M. A Longitudinal, 3-Month Serologic Assessment of SARS-CoV-2 Infections in a Belgian Hemodialysis Facility. Clin J Am — View Citation

Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shch — View Citation

Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, — View Citation

Mitchell TC, Casella CR. No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines. Curr Opin Immunol. 2017 Aug;47:17-25. doi: 10.1016/j.coi.2017.06.009. Epub 2017 Jul 17. Review. — View Citation

Scharpé J, Evenepoel P, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Peetermans WE. Influenza vaccination is efficacious and safe in renal transplant recipients. Am J Transplant. 2008 Feb;8(2):332-7. Epub 2007 Dec 19. — View Citation

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, Fen — View Citation

Windpessl M, Bruchfeld A, Anders HJ, Kramer H, Waldman M, Renia L, Ng LFP, Xing Z, Kronbichler A. COVID-19 vaccines and kidney disease. Nat Rev Nephrol. 2021 May;17(5):291-293. doi: 10.1038/s41581-021-00406-6. Epub 2021 Feb 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine one year
Primary 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 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 one year
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