mRNA-1469 Vaccine for Ebola
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new vaccine, mRNA-1469, developed to protect against Ebola. Participants will receive one of three different doses of the vaccine or a placebo (a harmless substance with no effect) to compare reactions. The trial seeks individuals who are generally healthy or have stable medical conditions and have not participated in previous Ebola vaccine studies.
As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that mRNA-1469 is likely to be safe for humans?
Research has shown that the mRNA-1469 vaccine is undergoing tests to determine its safety for people. In earlier animal tests, the vaccine protected mice from Ebola virus symptoms. These results are promising, but the research process is still in its early stages.
Currently, the vaccine is in the first phase of human trials, focusing on its safety and tolerability. Early trials like this one often assess any side effects or reactions. So far, detailed information about its safety in humans is not yet available.
As the vaccine remains in early testing stages, researchers are closely monitoring for any side effects. Such careful observation is standard for new treatments tested in humans for the first time.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the mRNA-1469 vaccine for Ebola because it uses a cutting-edge mRNA technology to potentially generate a strong immune response. Unlike traditional vaccines that use weakened or inactivated forms of the virus, mRNA-1469 works by instructing cells to produce a protein that triggers an immune response, offering a novel approach to Ebola prevention. This innovative mechanism could lead to faster development and production times compared to conventional methods, which is crucial in responding to outbreaks swiftly.
What evidence suggests that the mRNA-1469 vaccine could be an effective treatment for Ebola?
Research has shown that mRNA vaccines for Ebola have been promising in animal studies. Specifically, an mRNA vaccine targeting a part of the Ebola virus protected mice from illness and death. This trial will test the mRNA-1469 vaccine in humans, with participants receiving different dose levels. Additionally, other Ebola vaccines have successfully generated immune responses in about 84% of vaccinated individuals. This suggests a strong likelihood that mRNA-1469 could elicit a robust immune response against the Ebola virus.34567
Are You a Good Fit for This Trial?
This trial is for healthy adults who want to help test a new vaccine to prevent Ebola-Bundibugyo virus disease. Participants should not have major health problems or conditions that could affect their immune system.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 injection of mRNA-1469 or placebo at various dose levels on Day 1
Follow-up
Participants are monitored for safety and reactogenicity after receiving the injection
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1469
Trial Overview
The study is testing the safety and immune response of an experimental mRNA-1469 vaccine compared to a placebo. Participants are randomly assigned to receive either the vaccine or a placebo injection.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris
Citations
An mRNA vaccine encoding the Ebola virus glycoprotein ...
In both studies, the EBOV mRNA vaccine fully protected the mouse cohorts against morbidity and mortality.
Use of Ebola Vaccines — Worldwide, 2021–2023 | MMWR
Out of the 145,690 doses shipped 95% (139,120) have been repurposed for preventive vaccination, and 5% (6,570) were used in outbreak response.
Ebola Virus Disease Vaccines: Development, Current ...
A phase 2 clinical trial found that 83.7% of vaccinations produced EBOV GP-specific antibody responses, in comparison to 2.8% in the control group, as assessed ...
4.
cepi.net
cepi.net/modernas-bundibugyo-ebolavirus-vaccine-candidate-enters-first-human-trial-backed-cepiModerna's Bundibugyo ebolavirus vaccine candidate ...
Researchers will assess whether Moderna's mRNA-1469 vaccine candidate is safe and well tolerated, and whether it generates immune responses
5.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/moderna-kicks-off-phase-i-ebola-trial-as-africa-readies-itself-for-research/Moderna kicks off Phase I Ebola trial as Africa readies itself ...
Moderna's mRNA-1469 is designed to prevent Bundibugyo ebolavirus disease. committed up to $50m to support preclinical testing and the Phase I ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-the-safety-reactogenicity-and-immunogenicity-of-mrna-1469-vaccine-to-prevenA Study to Investigate the Safety, Reactogenicity, and ...
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469 Enrollment 84 estimated patients Sex All Ages 18 to ...
Moderna mRNA-1469 Ebola Vaccine | Bundibugyo Strain ...
the 44% rate remains extremely high. Preliminary safety and immunogenicity data are expected in the coming months.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.