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

Maria Joyera Rodríguez

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Covid19

Interventions

MRNA-1273DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

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).

Time frame: 4 months

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.

Time frame: 4 months

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.

Time frame: 4 months

Data from ClinicalTrials.gov

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