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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04930770

Acronym

VAX-TRES

Enrollment

Registered

2021-06-18

Start date

2021-09-30

Completion date

2022-03-01

Last updated

2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

vaccine

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.

Interventions

DRUGMRNA-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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with development of cellular and humoral immunity against SARS-CoV-2	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

Measure	Time frame	Description
Number of patients with development of cellular and humoral immunity against SARS-CoV-2	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	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	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026