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: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Joyera Rodríguez

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.