"Effects of the Vaccin Against COVID 19 in a Cohort of Dialysis Patients: Adverse Events and Immunological Response"

NCT05055531 | Unknown

• 1 other identifier: CHIM-GHT : RNI-3_02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The pandemic caused by COVID 19 continues to pose a threat to public health worldwide. Currently, approximately 2,397,312 people have died from it and 108,715,375 confirmed cases have been reported, according to the World Health Organization (WHO) as of February 13, 2021. Patients with chronic kidney disease (CKD) are, from stage 3, at risk for a severe form of COVID 19 and this risk increases with the severity of the disease, including in dialysis or transplant patients according to the press release. HAS of December 2020. As a result, France has prioritized vaccination for these patients the mRNA vaccine Therefore, the objective of this work is to study the safety of the vaccine in a population of hemodialysis patients in a heavy center, and the efficacy on the immune response (IgG) and the kinetics induced after 3 doses of the anti-Covid vaccine. to RNA.

Conditions

COVID Epidemic

Keywords

dialysis patients; vaccination; immunological response; mRNA vaccine; Vaccine safety; adverse event

Outcome Measures

Primary Outcomes (1)

• Vaccine safety

  number of clinical adverse events and consequences on dialysis treatment related to vaccination against SARS COV 2

  6 months

Secondary Outcomes (1)

• the immunological response

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease (CKD) are, from stage 3, or a population of hemodialysis patients at risk of severe form of COVID 19

You may qualify if:

• Chronic prevalent hemodialysis patients (for more than 3 months) performing 2 to 3 sessions / week, at least 3 hours, at the André Grégoire hospital center, Montreuil.
• Age\> 18 years old,
• Vaccination of at least one dose of Pfizer or Moderna vaccine from January 1, 2021, performed during a dialysis session.
• Affiliation to a social security scheme;

You may not qualify if:

• Acute hemodialysis (duration \<3 months).
• Patient who died before the first vaccine dose.
• Age \<18 years old
• Inability to give consent (eg mental retardation, patient under guardianship or legal protection, decompensated psychiatric illness, too advanced dementia (MMS \<15/30, etc.)
• Pregnant women
• Patient participating in another interventional study

Sponsors & Collaborators

• Raincy Montfermeil Hospital Group: lead

Study Sites (1)

GAUTHIER

Montreuil, 93100, France

RECRUITING

Central Study Contacts

Marion GAUTHIER, MD

CONTACT

+ 33 01 49 20 30 65; marion.gauthier@ght-gpne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 24, 2021
• Study Start: August 8, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)