mRNA-1189 for EBV Infection

No longer recruiting at 21 trial locations
MC
MW
Overseen ByModerna WeCare Team
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ModernaTX, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called mRNA-1189, an experimental vaccine designed to address Epstein-Barr Virus (EBV) infections. Researchers primarily assess the treatment's safety and its effects on the body's response. The study includes different groups, with some receiving varying doses of mRNA-1189 and others receiving a placebo, a harmless inactive substance. It seeks healthy individuals aged 18 to 30 and adolescents aged 12 to under 18 who have not been exposed to EBV. Participants will receive three injections over several months, with their health and reactions closely monitored. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a chronic illness that requires ongoing medication changes, you may not be eligible to participate.

Is there any evidence suggesting that mRNA-1189 is likely to be safe for humans?

Researchers are conducting studies to determine the safety and tolerability of mRNA-1189. Some studies focus on the body's response and safety for individuals aged 18 to 30, as well as for 12 to 17-year-olds who have never contracted the Epstein-Barr virus (EBV).

Currently, detailed information about side effects or negative reactions to mRNA-1189 is unavailable. The study remains in its early stages, primarily assessing safety and tolerability. Early studies often test various doses to identify the safest amount.

It's important to note that mRNA-based vaccines, like those for COVID-19, have generally been well-received, although each treatment differs. Participation in the trial will help researchers gather more information about the safety of mRNA-1189.12345

Why do researchers think this study treatment might be promising for EBV infection?

Researchers are excited about mRNA-1189 because it represents a novel approach to tackling Epstein-Barr Virus (EBV) infections. Unlike traditional antiviral medications or symptomatic treatments, mRNA-1189 uses messenger RNA technology to potentially train the immune system to recognize and fight the virus more effectively. This innovative mechanism could offer a more targeted and efficient way to manage EBV infections. Moreover, the use of mRNA technology, similar to recent advancements in vaccine development, suggests a promising new direction for creating treatments that are both effective and quick to produce.

What evidence suggests that mRNA-1189 might be an effective treatment for EBV infection?

Research shows that mRNA-1189, a new vaccine tested in this trial, is designed to protect against the Epstein-Barr Virus (EBV). This vaccine functions similarly to the COVID-19 mRNA vaccines, which have proven very effective. Although specific data on mRNA-1189's effectiveness in preventing EBV is not yet available, it is expected to help the immune system fight the virus or lessen the severity of the infection. Early studies on similar mRNA vaccines have shown promising results. Overall, mRNA-1189 aims to reduce the impact of EBV, a virus that can cause infectious mononucleosis, often called "mono" or "the kissing disease." Participants in this trial will receive different dose levels of mRNA-1189 or a placebo to evaluate its effectiveness and safety.24567

Are You a Good Fit for This Trial?

Inclusion Criteria

You must be between 12 and 17 years old to participate.
If you are a woman, you cannot be pregnant or breastfeeding during their trial participation.
You are in stable health, including having an underlying condition that’s well-controlled.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intramuscular injections of mRNA-1189 or placebo on Days 1, 57, and 169

24 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1189
How Is the Trial Designed?
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group II: Part C: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group III: Part C: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Group IV: Part B: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Group V: Part B: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group VI: Part B: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group VII: Part B: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Group VIII: Part A: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Group IX: Part A: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group X: Part A: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group XI: Part C: PlaceboPlacebo Group1 Intervention
Group XII: Part A: PlaceboPlacebo Group1 Intervention
Group XIII: Part B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

NCT05164094 | A Study of an Epstein-Barr Virus (EBV) ...The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults.
A Clinical Trial of an Epstein-Barr Virus (EBV) Vaccine in ...The Eclipse Trial is evaluating the safety and immune response of an investigational vaccine, called mRNA-1189, that may protect against infectious ...
The Status and Prospects of Epstein–Barr Virus ...78.0% efficacy in preventing IM, no efficacy in preventing asymptomatic EBV infection ... results showed that the AMMO1 antibody could inhibit EBV infection.
Urgency and necessity of Epstein-Barr virus prophylactic ...mRNA vaccines for SARS-CoV-2 showed potent protective effects. Recently, Moderna Inc. announced the initiation of a phase I study for its EBV ...
The growing interests in Epstein–Barr virus: A bibliometric ...... EBV infection will solve the public health burden caused by EBV infection. As reported, a mRNA-based vaccine termed mRNA-1189 developed by Moderna Inc is ...
The Potential for EBV Vaccines to Prevent Multiple SclerosisA Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 ... Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350 ...
A clinical trial of an Epstein-Barr virus (EBV) vaccine ...The Eclipse Trial is evaluating the safety and immune response of an investigational vaccine, called mRNA-1189, which aims to protect against Epstein-Barr virus ...
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