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 Rodríguez0 sitesSeptember 1, 2021

ConditionsCovid19

InterventionsMRNA-1273

DrugsMRNA-1273

Overview

Phase: Phase 2
Intervention: MRNA-1273
Conditions: Covid19
Sponsor: Maria Joyera Rodríguez
Primary Endpoint: Number of patients with development of cellular and humoral immunity against SARS-CoV-2
Status: Withdrawn
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2021

End Date

March 1, 2022

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Maria Joyera Rodríguez

Responsible Party

Sponsor Investigator

Principal Investigator

Maria Joyera Rodríguez

Clinical Research Manager

Fundacion Clinic per a la Recerca Biomédica

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Renal transplantation \< 3 months;
•Pregnancy or lactation status;
•Rejection treated within the last 6 months;
•Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.

Arms & Interventions

Renal/renopancreatic transplant's patients with a verified seronegativity

Intervention: MRNA-1273

Outcomes

Primary Outcomes

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 Outcomes

Number of patients with development of cellular and humoral immunity against SARS-CoV-2(4 months)
patient characteristics associated with biological non-response to vaccination(4 months)
Incidence of Treatment-Emergent Adverse Events(4 months)