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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)

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ClinicalTrials.gov Identifier: NCT04930770
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Joyera Rodríguez, Fundacion Clinic per a la Recerca Biomédica

Tracking Information
First Submitted Date  ICMJE June 3, 2021
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date June 18, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE Drug: MRNA-1273
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.
Study Arms  ICMJE Experimental: Renal/renopancreatic transplant's patients with a verified seronegativity
Intervention: Drug: MRNA-1273
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > 18 years;
  2. Male or female sex;
  3. Renal transplant with stable renal function in the last 2 months prior to study inclusion.
  4. 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.
  5. Patient giving written informed consent.

Exclusion Criteria:

  1. Renal transplantation < 3 months;
  2. Pregnancy or lactation status;
  3. Rejection treated within the last 6 months;
  4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fritz Diekmann +34 932275400 FDIEKMAN@clinic.cat
Contact: David Cucchiari CUCCHIARI@clinic.cat
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04930770
Other Study ID Numbers  ICMJE 2021-002356-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Joyera Rodríguez, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Maria Joyera Rodríguez
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP