Covid19 Clinical Trial
— Sputnik-HDOfficial 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
NCT number | NCT04805632 |
Other study ID # | Sputnik_HD |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2021 |
Est. completion date | January 30, 2022 |
Verified date | April 2024 |
Source | Saint Petersburg State University, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 52 |
Est. completion date | January 30, 2022 |
Est. primary completion date | January 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - A history of previous COVID-19 disease - Active malignancy of any localization - Human Immunodeficiency Virus (HIV) infection - Maintenance treatment with immunosuppressive therapy. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Saint-Petersburg State University Hospital | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Saint Petersburg State University, Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Humoral response to vaccination against against SARS-CoV-2 as compared to controls | SARS-CoV2 IgG levels | 28 days after the second vaccination | |
Secondary | Humoral response to vaccination against against SARS-CoV-2 | SARS-CoV2 IgG levels | 22 weeks after the second vaccination | |
Secondary | T-cell response against SARS-CoV-2 | SARS-CoV-2 specific T-cell subtype measured by interferon-? release assays (IGRA) | 28 days after the second vaccination | |
Secondary | T-cell response against SARS-CoV-2 | SARS-CoV-2 specific T-cell subtype measured by interferon-? release assays (IGRA) | 22 weeks after the second vaccination | |
Secondary | SARS-CoV-2 incidence | Survey of the incidence of SARS-CoV-2 infections over the study period | 22 weeks after the second vaccination |
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