Back to resultsStudy About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination (VAX-TRES)
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MRNA-1273
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring vaccine
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years;
- Male or female sex;
- Renal transplant with stable renal function in the last 2 months prior to study inclusion.
- Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
- Patient giving written informed consent.
Exclusion Criteria:
- Renal transplantation < 3 months;
- Pregnancy or lactation status;
- Rejection treated within the last 6 months;
- Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renal/renopancreatic transplant's patients with a verified seronegativity
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with development of cellular and humoral immunity against SARS-CoV-2
the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen
Secondary Outcome Measures
Number of patients with development of cellular and humoral immunity against SARS-CoV-2
development of cellular and humoral immunity against SARS-CoV-2 after 4 months of administration of a third dose of mRNA-1273 vaccine (Moderna).
patient characteristics associated with biological non-response to vaccination
Analysis of baseline factors associated with biological non-response to vaccination, including demographics, comorbidities, and transplant-associated factors. The following items will be reviewed: age, sex, diabetes, type of transplant (kidney-pancreas versus kidney), treatment with anti-thymocyte globulins (ATG) during the last year, lymphopenia defined as < 1000/mm3, time from transplantation < 1 year, eGFR (CKD-EPI), baseline immunosuppression, according to individual drug or the combination received by the patient, type of donor, BMI, ethnicity and blood type.
Incidence of Treatment-Emergent Adverse Events
Percentage of patients with mild and/or severe adverse events after administration of the third dose (safety and tolerability). Number of participants with treatment-related adverse events as assessed by the WHO toxicity scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930770
Brief Title
Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
Acronym
VAX-TRES
Official Title
Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No candidates for the trial (all patients have received the third dose of the vaccine)
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Joyera Rodríguez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal/renopancreatic transplant's patients with a verified seronegativity
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MRNA-1273
Intervention Description
Renal or renopancreatic transplant's patient will receive a third dose of mRNA 1273 (Moderna) vaccine from 28 days after administration of the second dose and after the seronegativity has been verified.
Primary Outcome Measure Information:
Title
Number of patients with development of cellular and humoral immunity against SARS-CoV-2
Description
the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of patients with development of cellular and humoral immunity against SARS-CoV-2
Description
development of cellular and humoral immunity against SARS-CoV-2 after 4 months of administration of a third dose of mRNA-1273 vaccine (Moderna).
Time Frame
4 months
Title
patient characteristics associated with biological non-response to vaccination
Description
Analysis of baseline factors associated with biological non-response to vaccination, including demographics, comorbidities, and transplant-associated factors. The following items will be reviewed: age, sex, diabetes, type of transplant (kidney-pancreas versus kidney), treatment with anti-thymocyte globulins (ATG) during the last year, lymphopenia defined as < 1000/mm3, time from transplantation < 1 year, eGFR (CKD-EPI), baseline immunosuppression, according to individual drug or the combination received by the patient, type of donor, BMI, ethnicity and blood type.
Time Frame
4 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
Percentage of patients with mild and/or severe adverse events after administration of the third dose (safety and tolerability). Number of participants with treatment-related adverse events as assessed by the WHO toxicity scale.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years;
Male or female sex;
Renal transplant with stable renal function in the last 2 months prior to study inclusion.
Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
Patient giving written informed consent.
Exclusion Criteria:
Renal transplantation < 3 months;
Pregnancy or lactation status;
Rejection treated within the last 6 months;
Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
12. IPD Sharing Statement
Learn more about this trial
Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
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