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

NCT05280158 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 22-000192
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SARS-CoV-2; lung transplant recipient; immunosuppression

Outcome Measures

Primary Outcomes (3)

• Participants Experiencing Solicited Local and Systemic Reactogenicity Adverse Reactions (AR)

  Solicited local and systemic reactogenicity adverse events were documented daily in a dedicated diary, and assigned a grade 1-3 according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA grading scale). Higher grades are assigned to more severe events.

  Day 1 - Day 7 after study drug administration

• Participants Reporting Unsolicited Adverse Events (AEs) Recorded on a Daily Diary

  Comprehensive recording of occurrence and severity grade of unsolicited adverse events (AEs) daily. These events were documented in a dedicated diary starting from Day 1 of the study and continued through to Day 30. Data collection encompassed adverse events not specifically solicited, with each event's frequency recorded for analysis.

  Day 1 - Day 30 after study drug administration

• Participants Reporting Any Serious Adverse Experiences (SAEs) and Adverse Events of Special Interests (AESIs) Related to the Intervention From Day 1 Until Day 180.

  This comprehensive data collection is intended to provide insights into the occurrence of significant adverse events and specific adverse events of interest over an extended period

  Day 1 - Day 180 after study drug administration

Secondary Outcomes (4)

• Humoral Immunogenicity Measured by Anti-RBD and Anti-spike (S-2P) IgG Levels at Day 30.

  Day 30 after study drug administration

• Humoral Immunogenicity Measured by Neutralizing Antibody Titers From a Pseudovirus Neutralization Assay at Day 30.

  Day 1, Day 30 after study drug administration

• Cellular Immunogenicity (CD8+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.

  Day 1, Day 30 after study drug administration

• Cellular Immunogenicity (CD4+ T Cell Responses After Spike Protein Peptide Pool Stimulation) Measured by Cellular Response Assays Including Flow Cytometry With Intracellular Staining.

  Day 1, Day 30 after study drug administration

Study Arms (3)

Standard-dose

ACTIVE COMPARATOR

mRNA-1273 (Moderna COVID-19 vaccine) 50 ug

Drug: mRNA-1273 (Moderna COVID-19 vaccine)

Mid-Dose

EXPERIMENTAL

mRNA-1273 (Moderna COVID-19 vaccine) 100 ug

Drug: mRNA-1273 (Moderna COVID-19 vaccine)

High-Dose

EXPERIMENTAL

mRNA-1273 (Moderna COVID-19 vaccine) 200 ug

Drug: mRNA-1273 (Moderna COVID-19 vaccine)

Interventions

mRNA-1273 (Moderna COVID-19 vaccine) DRUG

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

High-Dose; Mid-Dose; Standard-dose

Eligibility Criteria

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

You may not qualify if:

• Previous documented COVID-19 infection.
• Use of investigational agents for prophylaxis against COVID-19 within 90 days of the start of the study, including Evusheld monoclonal antibodies.
• Ongoing therapy for acute cellular or antibody mediated rejection.
• Intravenous immunoglobulins (IVIG) administration within the prior 3 months or ongoing IVIG therapy.
• Anaphylaxis or allergic reaction to any prior vaccines.
• History of anaphylaxis or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
• Is acutely ill or febrile 24 hours prior to or at the Day 1 visit. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• Pregnant or breastfeeding.
• Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
• Known history of hypertension (HTN) with systolic blood pressure (BP) \> 180 mm Hg at the Day 1 visit.
• Known history of hypotension with systolic blood pressure \< 85 mm Hg at the Day 1 visit.
• Bleeding disorder considered a contraindication to IM injection or phlebotomy.
• Active malignancy diagnosed within previous 4 years (excluding non-melanoma skin cancer).
• Received a major surgery including lung transplantation in the past 3 months.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• ModernaTX, Inc.: collaborator

Study Sites (1)

UCLA Clinical Translational Research Center

Los Angeles, California, 90095, United States

Location

Related Publications (30)

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MeSH Terms

Interventions

2019-nCoV Vaccine mRNA-1273

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

Results Point of Contact

• Title: Yusaku Michael Shino, MD
• Organization: University of California, Los Angeles

MShino@mednet.ucla.edu

(310) 866-6327

Study Officials

• Yusaku Michael Shino, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Groups will be enrolled as follows: 1. Mid-dose - Sentinel group, n=2 2. Standard-dose - Initial group, n=2 3. Cohort 1: 2:1 Randomization into * Mid-dose group, n=18 * Standard-dose group, n=9 4. High-dose - Sentinel group, n=2 5. Cohort 2: 2:1 Randomization into * High-dose group, n=18 * Standard-dose group, n=9 We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines.

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: March 15, 2022
• Study Start: March 10, 2022
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)