Covid19Sputnik-HDNCT04805632
Immune Response in Dialysis Patients Vaccinated Against COVID-19
An observational study of Covid19 and Chronic Kidney Disease 5D, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Chronic Kidney Disease 5D
- Type of treatment
- Vaccines
- How many people
- 52 participants
- Where
- 1 siteRussia
- Study dates
- 23 Mar 2021to 30 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.
Who may be able to join
- Age of 18 years or older
- Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine
- Written informed consent.
Who cannot join
- A history of previous COVID-19 disease
- Active malignancy of any localization
- Human Immunodeficiency Virus (HIV) infection
- Maintenance treatment with immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
About this study
Official title: A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine
This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).
Read the detailed description
Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group.
Study design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine.
Blood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration.
The primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls.
The secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.
- Conditions
- Covid19, Chronic Kidney Disease 5D
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis | Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection | |
| Healthy | Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral response to vaccination against against SARS-CoV-2 as compared to controls
SARS-CoV2 IgG levels
Measured: 28 days after the second vaccination
Secondary outcomes (4)
Humoral response to vaccination against against SARS-CoV-2
SARS-CoV2 IgG levels
Measured: 22 weeks after the second vaccination
T-cell response against SARS-CoV-2
SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)
Measured: 28 days after the second vaccination
T-cell response against SARS-CoV-2
SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)
Measured: 22 weeks after the second vaccination
SARS-CoV-2 incidence
Survey of the incidence of SARS-CoV-2 infections over the study period
Measured: 22 weeks after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start23 Mar 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Parshina, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805632
- Sponsor's protocol ID
- Sputnik_HD
- Acronym
- Sputnik-HD
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine
- ClinicalTrials.gov ID
- NCT04805632
- Acronym / sponsor ID
- Sputnik-HD / Sputnik_HD
- Conditions
- Covid19, Chronic Kidney Disease 5D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 18 Mar 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.
This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).
Detailed description
Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group.
Study design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine.
Blood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration.
The primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls.
The secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysis | – | –Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection |
| Healthy | – | –Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.
Key inclusion criteria (3 listed)
- Age of 18 years or older
- Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine
- Written informed consent.
Key exclusion criteria (4 listed)
- A history of previous COVID-19 disease
- Active malignancy of any localization
- Human Immunodeficiency Virus (HIV) infection
- Maintenance treatment with immunosuppressive therapy.
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
Humoral response to vaccination against against SARS-CoV-2 as compared to controls
Time frame: 28 days after the second vaccination
SARS-CoV2 IgG levels
4 secondary outcomes
Humoral response to vaccination against against SARS-CoV-2
Time frame: 22 weeks after the second vaccination
T-cell response against SARS-CoV-2
Time frame: 28 days after the second vaccination
T-cell response against SARS-CoV-2
Time frame: 22 weeks after the second vaccination
SARS-CoV-2 incidence
Time frame: 22 weeks after the second vaccination
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 18 Apr 2024.
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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.
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 Covid19 and Chronic Kidney Disease 5D, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 3 inclusion and 4 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 18 Apr 2024. 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 Russia. 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?
Humoral response to vaccination against against SARS-CoV-2 as compared to controls (time frame: 28 days after the second vaccination). 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 18 Apr 2024.