What side effects are associated with this type of intervention?

The most common side effects of messenger RNA (mRNA) vaccines, such as those being studied for EBV infection (e.g., mRNA-1195), typically include local reactions at the injection site (pain, redness, swelling), systemic reactions like fever, fatigue, headache, muscle pain, chills, and joint pain. These side effects are generally mild to moderate and resolve within a few days. For other treatments of EBV, such as antiviral medications, side effects can include gastrointestinal disturbances, headache, dizziness, and in some cases, more severe reactions like nephrotoxicity or bone marrow suppression. It is important to discuss potential side effects with a healthcare provider to understand the risks and benefits of the treatment.

What prior FDA approvals exist?

There are no specific mentions of prior FDA approvals for mRNA-based therapies or vaccines for the treatment of Epstein-Barr Virus (EBV) infection in the provided context. The study of mRNA-1195 is focused on evaluating the safety and reactogenicity of this candidate vaccine in healthy adults. Generally, treatments for EBV infections are limited, and there are no widely approved vaccines or antiviral therapies specifically targeting EBV. Management typically involves supportive care and symptomatic treatment.

What other types of research exist?

Promising novel alternatives to mRNA-1195 for EBV infection include other mRNA-based vaccines targeting different viral antigens, peptide-based vaccines, and viral vector vaccines. Additionally, immunotherapies such as adoptive T-cell therapy and monoclonal antibodies targeting EBV-specific proteins are being explored. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment based on the latest research and individual health status.

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Cancer Vaccine

mRNA EBV Vaccine for EBV Infection

Phase 1

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests the safety of a new vaccine called mRNA-1195 in healthy adults. The study is split into two parts based on whether participants have been exposed to Epstein-Barr Virus. The vaccine works by teaching the body to recognize and fight the virus.

Who is the study for?

This trial is for healthy adults aged 18-55 who either have been exposed to EBV (Part A) or not (Part B). Participants must be in good health, able to follow the study plan, and if female and able to become pregnant, they must use effective birth control. People with recent fevers, unstable chronic illnesses, drug/alcohol abuse history, or those on certain immune-altering drugs can't join.

What is being tested?

The study tests the safety of an Epstein-Barr Virus vaccine called mRNA-1195 in two forms (mRNA-1195.1 and mRNA-1195.2), comparing it against another candidate vaccine mRNA-1189 and a placebo. The goal is to see how participants' bodies react to these vaccines.

What are the potential side effects?

Possible side effects may include typical reactions at the injection site like pain or swelling, feverish symptoms shortly after vaccination, fatigue, headache or muscle pains which are common responses indicating that the body is building protection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

15Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part B: mRNA-1195.1 or mRNA-1195.2 Middle DoseExperimental Treatment2 Interventions

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.

Group II: Part B: mRNA-1195.1 or mRNA-1195.2 Low DoseExperimental Treatment2 Interventions

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.

Group III: Part B: mRNA-1195.1 or mRNA-1195.2 High DoseExperimental Treatment2 Interventions

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.

Group IV: Part A: mRNA-1195.2 Dose Level 4Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.

Group V: Part A: mRNA-1195.2 Dose Level 3Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.

Group VI: Part A: mRNA-1195.2 Dose Level 2Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.

Group VII: Part A: mRNA-1195.2 Dose Level 1Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.

Group VIII: Part A: mRNA-1195.1 Dose Level 4Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.

Group IX: Part A: mRNA-1195.1 Dose Level 3Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.

Group X: Part A: mRNA-1195.1 Dose Level 2Experimental Treatment1 Intervention

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.

Group XI: Part A: mRNA-1195.1 Dose Level 1Experimental Treatment1 Intervention

Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.

Group XII: Part A: mRNA-1189Active Control1 Intervention

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Group XIII: Part B: mRNA-1189Active Control1 Intervention

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Group XIV: Part B: PlaceboPlacebo Group1 Intervention

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Group XV: Part A: PlaceboPlacebo Group1 Intervention

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Epstein-Barr Virus (EBV) infection include antiviral therapies and vaccines. Antiviral therapies, such as ganciclovir and foscarnet, work by inhibiting viral DNA replication, thereby reducing viral load and limiting the spread of the virus. However, these treatments are not always effective and can have significant side effects. The mRNA-1195 vaccine, currently under study, represents a novel approach by using messenger RNA to instruct cells to produce viral proteins, thereby stimulating the immune system to recognize and combat EBV. This method aims to provide a more targeted and effective immune response, potentially offering better protection and fewer side effects compared to traditional antiviral therapies. For EBV infection patients, these advancements are crucial as they offer hope for more effective and safer treatment options.