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High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients

NCT05280158 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-26

Study results available
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Summary

Lung transplant recipients have poor outcomes after COVID-19 infection with mortality. Due to the immunosuppression, they have had poor responses to SARS-CoV-2 vaccine and remain at high risk of poor outcomes. This is a Phase I/II clinical trial to evaluate the safety and immune response from a higher dose mRNA-1273 vaccine among lung transplant recipients who have already received three or four doses of the COVID-19 vaccine.

Conditions

  • Lung Transplant Recipient
  • SARS-CoV-2
  • Immunosuppression

Interventions

DRUG

mRNA-1273 (Moderna COVID-19 vaccine)

Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.

Sponsors & Collaborators

Principal Investigators

  • Yusaku Michael Shino, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2023-02-27
Completion
2023-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280158 on ClinicalTrials.gov