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

NCT04930770 | Withdrawn Phase 2 DMC

• 2 other identifiers: VAX-TRES2021-002356-37
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Renal/renopancreatic transplant's patients with a verified seronegativity

EXPERIMENTAL

Drug: MRNA-1273

Interventions

MRNA-1273 DRUG

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.

Renal/renopancreatic transplant's patients with a verified seronegativity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Male or female sex;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Joyera Rodríguez: lead

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 18, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: June 22, 2025

Record last verified: 2025-06