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mRNA Vaccine

mRNA-0184 for Heart Failure

Q: What is the current intake threshold for participation in this research?

For this trial to be successful, 98 individuals that satisfy the inclusion criteria must enroll. Patients can join at locations such as University of <a href="https://www.withpower.com/clinical-trials/alabama">Alabama</a> at Birmingham: The Kirklin Clinic in Gainesville, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> and University of Florida in Jacksonville, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>.

Q: Has the FDA sanctioned SAD Stage: mRNA-0184?

Given the limited amount of clinical information available regarding SAD Stage: mRNA-0184, our team has assigned a score of 1 on its safety assessment scale. This is due to it being designated as a Phase I trial which indicates scarce evidence for both safety and efficacy.

Q: At which facilities is this clinical trial being conducted?

Currently, 15 medical sites are taking on participants for this trial. These facilities can be located in such cities as Gainesville, Jacksonville and Tullahoma among many others. To reduce commuting time associated with the treatment plan, it is best to select a clinic close by your residence.

Q: Are there any unfilled slots in this trial available for participants?

Affirmative. Perusal of the clinicaltrials.gov webpage indicates that this research is currently recruiting participants, having been initially posted on November 18th 2022 and most recently updated on September 29th 2023. 98 people are needed in total to be recruited from 15 different medical centres.

Phase 1

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New York Heart Association (NYHA) HF Class I or II

Documented diagnosis of heart failure (HF) based on medical records

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (within 60 minutes predose) up to day 183

Awards & highlights

Study Summary

This trial tests the safety of a potential new medicine when taken at different doses.

Who is the study for?

This trial is for adults with heart failure who have been on stable heart medication for at least 4 weeks. They should have a left ventricular ejection fraction between 35% and <50%, fall under NYHA HF Class I or II, and not be hospitalized for cardiovascular reasons recently. People can't join if they've had recent COVID-19 vaccination, angina symptoms, severe allergies to the drug's components, other clinical study participation recently, uncontrolled diabetes, certain heart diseases or severe lung problems.Check my eligibility

What is being tested?

The trial is testing mRNA-0184 against a placebo in people with chronic heart failure. It aims to find out how safe it is and how well participants tolerate different doses of this new treatment when given once or multiple times.See study design

What are the potential side effects?

Since the study focuses on safety and tolerability of mRNA-0184 in patients with heart failure, potential side effects are being investigated but are not specified here. Common side effects may include reactions at injection site, flu-like symptoms among others typical for vaccine-related interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart failure is mild to moderate.

Select...

I have been officially diagnosed with heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (within 60 minutes predose) up to day 183

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (within 60 minutes predose) up to day 183

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (within 60 minutes predose) up to day 183 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Secondary outcome measures

Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA

Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein

Maximum Observed Effect (Emax) of Rel2- vlk Protein

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SAD Stage: mRNA-0184Experimental Treatment1 Intervention

Participants will receive a single dose of mRNA-0184.

Group II: MAD Stage: mRNA-0184Experimental Treatment1 Intervention

Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.

Group III: MAD Stage: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,379,219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current intake threshold for participation in this research?

"For this trial to be successful, 98 individuals that satisfy the inclusion criteria must enroll. Patients can join at locations such as University of Alabama at Birmingham: The Kirklin Clinic in Gainesville, Florida and University of Florida in Jacksonville, Tennessee."

Answered by AI

Has the FDA sanctioned SAD Stage: mRNA-0184?

"Given the limited amount of clinical information available regarding SAD Stage: mRNA-0184, our team has assigned a score of 1 on its safety assessment scale. This is due to it being designated as a Phase I trial which indicates scarce evidence for both safety and efficacy."

Answered by AI

At which facilities is this clinical trial being conducted?

"Currently, 15 medical sites are taking on participants for this trial. These facilities can be located in such cities as Gainesville, Jacksonville and Tullahoma among many others. To reduce commuting time associated with the treatment plan, it is best to select a clinic close by your residence."

Answered by AI

Are there any unfilled slots in this trial available for participants?

"Affirmative. Perusal of the clinicaltrials.gov webpage indicates that this research is currently recruiting participants, having been initially posted on November 18th 2022 and most recently updated on September 29th 2023. 98 people are needed in total to be recruited from 15 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure

2022. "A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659264.