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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

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: MRNA-1273 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Renal/renopancreatic transplant's patients with a verified seronegativity 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Fritz Diekmann +34 932275400 FDIEKMAN@clinic.cat
Contact: David Cucchiari CUCCHIARI@clinic.cat

Sponsors and Collaborators
Maria Joyera Rodríguez
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Responsible Party: Maria Joyera Rodríguez, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT04930770    
Other Study ID Numbers: 2021-002356-37
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Joyera Rodríguez, Fundacion Clinic per a la Recerca Biomédica:
vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases