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Vaccine
High-Dose Moderna Booster for Lung Transplant Recipients
Phase 1 & 2
Waitlist Available
Led By Michael Shino, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - day 180 after study drug administration
Awards & highlights
Study Summary
This trial is to study the effects of a higher dose COVID-19 vaccine among lung transplant recipients who have had poor responses to the current vaccine.
Who is the study for?
This trial is for adult lung transplant recipients who have had 3 or 4 doses of Moderna or Pfizer COVID-19 vaccines at least 4 months ago. They must be in stable health, not pregnant, breastfeeding, or planning to become pregnant soon. Participants should be on a standard immunosuppression regimen and agree to avoid other COVID-19 prophylaxis during the study.Check my eligibility
What is being tested?
The trial tests if a higher dose of the Moderna mRNA-1273 vaccine boosts immunity in lung transplant patients already vaccinated with previous doses. It's a Phase I/II study focusing on safety and immune response.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; severe allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 - day 180 after study drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - day 180 after study drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and grade of each solicited local and systemic reactogenicity AE will be recorded on a daily diary using the FDA Toxicity Grading Scale and collected from Day 1 until Day 7.
Frequency and grade of each unsolicited adverse events (AEs) will be recorded on a daily diary and collected from Day 1 until Day 30.
Frequency of any serious adverse experiences (SAEs) and adverse events of special interests (AESIs) will be collected from Day 1 until Day 180.
Secondary outcome measures
Cellular immunogenicity measured by cellular response assays including flow cytometry with intracellular staining at Day 30.
Humoral immunogenicity measured by anti-RBD and anti-spike (S-2P) IgG levels at Day 30.
Humoral immunogenicity measured by neutralizing antibody titers from a pseudovirus neutralization assay at Day 30.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mid-DoseExperimental Treatment1 Intervention
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
Group II: High-DoseExperimental Treatment1 Intervention
mRNA-1273 (Moderna COVID-19 vaccine) 200 ug
Group III: Standard-doseActive Control1 Intervention
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,832 Total Patients Enrolled
21 Trials studying COVID-19
873,585 Patients Enrolled for COVID-19
ModernaTX, Inc.Industry Sponsor
107 Previous Clinical Trials
61,378,106 Total Patients Enrolled
37 Trials studying COVID-19
61,260,547 Patients Enrolled for COVID-19
Michael Shino, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken experimental medications to prevent COVID-19 in the last 90 days, including Evusheld monoclonal antibodies.You are currently receiving treatment for rejection of a transplanted organ.You have received IVIG treatment in the past 3 months or are currently receiving IVIG therapy.You had a severe allergic reaction to a vaccine before.You had COVID-19 before and it was confirmed by a doctor.You had a serious allergic reaction that needed medical help after getting a vaccine.You have received three or four doses of the Moderna or Pfizer COVID-19 vaccine at least 4 months before the study starts.Adults who had a lung transplant and got all their COVID-19 vaccines after the transplant.You have a history of very low blood pressure.You have a condition that makes it unsafe for you to receive injections or have blood drawn.You had a test that shows you are not pregnant at the beginning of the study.You had a big surgery, like a lung transplant, in the last 3 months.You have had cancer (except for non-melanoma skin cancer) in the past 4 years.You have a history of high blood pressure with a systolic blood pressure above 180 mm Hg at the Day 1 visit.You are currently taking a combination of three specific medications to suppress your immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Standard-dose
- Group 2: Mid-Dose
- Group 3: High-Dose
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrolment numbers still open for this research project?
"Yes, this is accurate. The most recent information on clinicaltrials.gov indicates that this study was posted on March 10th, 2022 and updated on August 29th, 2022."
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