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

Covid19 Clinical Trial

— VAX-TRES  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04930770
• Other study ID #: 2021-002356-37
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maria Joyera Rodríguez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Secondary	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).	4 months
Secondary	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.	4 months
Secondary	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.	4 months