COVID EpidemicVACOVEIRINCT05055531
"Effects of the Vaccin Against COVID 19 in a Cohort of Dialysis Patients: Adverse Events and Immunological Response"
An observational study of COVID Epidemic, run by Raincy Montfermeil Hospital Group at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID Epidemic
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2021to Jun 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GAUTHIER
Montreuil, 93100
Gauthier Marion, MD, 0149203097, marion.gauthier@ght-gpne.fr
About this study
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.
Read the detailed description
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 the mRNA vaccine vaccination for these patients in accordance with the vaccination strategy defined by the Minister of Health on Friday, January 15, 2021.
Phase 3 trials of RNA vaccines have shown good tolerability and greater than 90% efficacy in preventing symptomatic infection after two doses given 3 to 4 weeks apart , but hemodialysis patients did not not included in the first clinical trials of Covid-19 vaccination. Little is known about the immunological response to the COVID 19 vaccine, as is the need for new doses, given the usually low immune response in this population . Seroconversion after confirmed infection approaches 100% in the dialysis population, but the durability of this protective immune response remains uncertain. Some studies indicate that the IgG titers of COVID 19 decrease considerably after 3 months 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. All patients at the dialysis center were offered the coronavirus vaccine. The vaccination was carried out during a dialysis session. The vaccines administered were the only ones to have had Marketing Authorization from January 2021: Pfizer / BioNTech and Moderna. Not all patients were vaccinated at the same time. The first doses given to the first dialysis patients were given in January 2021, then the injections were staggered over time. In accordance with the recommendations of the Ministry of Health, patients were offered 3 doses of vaccine (from the same laboratory).
- Conditions
- COVID Epidemic
- Keywords
- dialysis patients, vaccination, immunological response, mRNA vaccine, Vaccine safety, adverse event
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine safety
number of clinical adverse events and consequences on dialysis treatment related to vaccination against SARS COV 2
Measured: 6 months
Secondary outcomes (1)
the immunological response
he immunological response by assaying the IgGs of dialysis patients from the second vaccine dose and in the 6 months that follow.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start8 Aug 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID EpidemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055531
- Sponsor's protocol ID
- CHIM-GHT : RNI-3_02
- Acronym
- VACOVEIRI
- Status last verified
- Feb 2022
- First submitted
- 17 Sep 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of the Vaccin Against COVID 19 in a Cohort of Dialysis Patients: Adverse Events and Immunological Response"
- ClinicalTrials.gov ID
- NCT05055531
- Acronym / sponsor ID
- VACOVEIRI / CHIM-GHT : RNI-3_02
- Conditions
- COVID Epidemic
- Keywords
- dialysis patients, vaccination, immunological response, mRNA vaccine, Vaccine safety, adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 the mRNA vaccine vaccination for these patients in accordance with the vaccination strategy defined by the Minister of Health on Friday, January 15, 2021.
Phase 3 trials of RNA vaccines have shown good tolerability and greater than 90% efficacy in preventing symptomatic infection after two doses given 3 to 4 weeks apart , but hemodialysis patients did not not included in the first clinical trials of Covid-19 vaccination. Little is known about the immunological response to the COVID 19 vaccine, as is the need for new doses, given the usually low immune response in this population . Seroconversion after confirmed infection approaches 100% in the dialysis population, but the durability of this protective immune response remains uncertain. Some studies indicate that the IgG titers of COVID 19 decrease considerably after 3 months 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. All patients at the dialysis center were offered the coronavirus vaccine. The vaccination was carried out during a dialysis session. The vaccines administered were the only ones to have had Marketing Authorization from January 2021: Pfizer / BioNTech and Moderna. Not all patients were vaccinated at the same time. The first doses given to the first dialysis patients were given in January 2021, then the injections were staggered over time. In accordance with the recommendations of the Ministry of Health, patients were offered 3 doses of vaccine (from the same laboratory).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccine safety
Time frame: 6 months
number of clinical adverse events and consequences on dialysis treatment related to vaccination against SARS COV 2
1 secondary outcome
the immunological response
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID Epidemic, run by Raincy Montfermeil Hospital Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion GAUTHIER, MD (+ 33 01 49 20 30 65, marion.gauthier@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.