Study about the response to the administration of a third dose of mRNA-1273 vaccine (COVID19 vaccine Moderna) in renal transplants with immunological failure initial to vaccinatio

Phase 1

• Conditions: COVID19 vaccine in kidney transplant patients; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002356-37-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica (FCRB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified