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 (VAX-TRES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04930770|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: MRNA-1273||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||August 1, 2021|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
|Experimental: Renal/renopancreatic transplant's patients with a verified seronegativity||
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.
- Number of patients with development of cellular and humoral immunity against SARS-CoV-2 [ Time Frame: 2 weeks ]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
- Number of patients with development of cellular and humoral immunity against SARS-CoV-2 [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04930770
|Contact: Fritz Diekmann||+34 932275400||FDIEKMAN@clinic.cat|
|Contact: David Cucchiari||CUCCHIARI@clinic.cat|