COVID-19 VaccinesROMANOVNCT04881396
Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
An observational study of COVID-19 Vaccines and Hemodialysis Complication, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- COVID-19 Vaccines, Hemodialysis Complication
- What is being tested?
- Evaluation of the immunogenicity of the vaccine in haemodialysis patients
- Type of treatment
- Vaccines
- How many people
- 99 participants
- Where
- 2 sitesFrance
- Study dates
- 10 May 2021to 15 Feb 2022
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2 mRNA Cov-19 with classical scheme
Who may be able to join
- Medical prescription of BTN162b2 mRNA Cov-19 vaccine
- Treatment by chronic (>1 month) haemodialysis
Who cannot join
- Non-recommended vaccination scheme
- Refusal to consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Nephrology, Hopital Edouard Herriot
Lyon, 69003
Department of Nephrology, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.
The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.
- Conditions
- COVID-19 Vaccines, Hemodialysis Complication
- Being tested
- Evaluation of the immunogenicity of the vaccine in haemodialysis patients
- Keywords
- immunogenicity, haemodialysis patients, SARS-Cov2 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the immunogenicity of the vaccine in haemodialysis patientsBiological
The immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells)
| Study group | Role | What they receive |
|---|---|---|
| All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine | Serological response is defined by a 4 fold increase of IgG anti-spike protein of SARS-Cov2 between Day 0 (before vaccination) and after complete vaccination (evaluated at Day 7 - 14 post-boost). Receives: Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
IgG anti SARS-Cov2 spike protein will be evaluated by ELISA at Day 0 (at the initiation of vaccination) anti Day 7 - Day 14 after the second dose (peak of response).
The seroconversion is defined by an 4 fold increase of IgG anti SARS-Cov2 spike protein titer between Day 0 and Day 7 - Day 14 after second dose.
Measured: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start10 May 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881396
- Sponsor's protocol ID
- 69HCL21_0125
- Other IDs
- 2021-A00325-36
- Acronym
- ROMANOV
- Status last verified
- May 2022
- First submitted
- 4 May 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
- ClinicalTrials.gov ID
- NCT04881396
- Acronym / sponsor ID
- ROMANOV / 69HCL21_0125
- Conditions
- COVID-19 Vaccines, Hemodialysis Complication
- Keywords
- immunogenicity, haemodialysis patients, SARS-Cov2 vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 11 May 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.
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.
The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine | – | Biological: Evaluation of the immunogenicity of the vaccine in haemodialysis patientsSerological response is defined by a 4 fold increase of IgG anti-spike protein of SARS-Cov2 between Day 0 (before vaccination) and after complete vaccination (evaluated at Day 7 - 14 post-boost). |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2 mRNA Cov-19 with classical scheme
Key inclusion criteria (2 listed)
- Medical prescription of BTN162b2 mRNA Cov-19 vaccine
- Treatment by chronic (>1 month) haemodialysis
Key exclusion criteria (2 listed)
- Non-recommended vaccination scheme
- Refusal to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the immunogenicity of the vaccine in haemodialysis patientsThe immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells) | Biological | All haemodialysed patients with a medical prescription of BTN162b2 mRNA Cov-19 vaccine |
Primary outcome
Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
Time frame: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
IgG anti SARS-Cov2 spike protein will be evaluated by ELISA at Day 0 (at the initiation of vaccination) anti Day 7 - Day 14 after the second dose (peak of response). The seroconversion is defined by an 4 fold increase of IgG anti SARS-Cov2 spike protein titer between Day 0 and Day 7 - Day 14 after second dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccines and Hemodialysis Complication, run by Hospices Civils de Lyon at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine (time frame: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.). 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 10 May 2022.