What side effects are associated with this type of intervention?

The most common treatments for Norovirus are supportive care measures, as there are no specific antiviral drugs approved for this virus. However, mRNA-based vaccines, like those being studied in the trial mRNA-1403 and mRNA-1405, are designed to instruct cells to produce a protein that elicits an immune response. Known side effects of mRNA-based vaccines, similar to those observed with COVID-19 mRNA vaccines, include injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days.

What prior FDA approvals exist?

As of now, there are no FDA-approved mRNA-based vaccines or treatments specifically for Norovirus. The mRNA-1403 and mRNA-1405 vaccines are currently under investigation to evaluate their safety, reactogenicity, and immunogenicity. These investigational vaccines work by instructing cells to produce a protein that elicits an immune response, a mechanism similar to the mRNA vaccines developed for COVID-19. Current treatments for Norovirus are primarily supportive, focusing on hydration and symptom management.

What other types of research exist?

As of 2024, promising novel alternatives to mRNA-1403 and mRNA-1405 for Norovirus treatment include other mRNA-based vaccines that are in advanced stages of clinical trials. Additionally, monoclonal antibody therapies, which have shown efficacy in preventing viral infections, could be considered. These treatments work by targeting specific proteins of the virus, thereby neutralizing it and preventing infection. Another innovative approach could be the use of viral vector-based vaccines, which use a different virus to deliver Norovirus antigens and elicit an immune response.

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Virus Therapy

mRNA Vaccines for Norovirus

Phase 1 & 2

Recruiting

Research Sponsored by ModernaTX, Inc.

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 phase 1: days 1, 29, and 57; phase 2: days 1 and 29

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of two potential vaccines for adults aged 18-49 and 60-80.

Who is the study for?

Healthy adults aged 18-49 and 60-80 with a BMI of 18-39 kg/m^2 can join. Women must not be pregnant or breastfeeding and using effective contraception. Exclusions include bleeding disorders, acute illness, unstable medical conditions, immunosuppression, history of myocarditis/pericarditis, recent other vaccines or blood donations.Check my eligibility

What is being tested?

The trial is testing mRNA vaccines (mRNA-1403 and mRNA-1405) against norovirus gastroenteritis in two age groups: young adults (18-49) and older adults (60-80). Participants will receive either the vaccine candidates or a placebo to assess safety and immune response.See study design

What are the potential side effects?

Possible side effects may include local reactions at the injection site, feverish symptoms similar to mild flu-like symptoms, fatigue, headache, muscle pain. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1: days 1, 29, and 57; phase 2: days 1 and 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1: days 1, 29, and 57; phase 2: days 1 and 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1: days 1, 29, and 57; phase 2: days 1 and 29 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 Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and Adverse Events of Special Interest (AESIs)

Number of Participants with Medically Attended AEs (MAAEs)

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

+1 more

Secondary outcome measures

GMFR of bAb Levels

Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes

Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers

+3 more

Trial Design

15Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 2 Part: mRNA-1403 Dose Level 3Experimental Treatment1 Intervention

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3.

Group II: Phase 2 Part: mRNA-1403 Dose Level 2Experimental Treatment1 Intervention

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 2.

Group III: Phase 2 Part: mRNA-1403 Dose Level 1Experimental Treatment1 Intervention

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1.

Group IV: Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 2Experimental Treatment2 Interventions

Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.

Group V: Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 1Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.

Group VI: Phase 1 Part: mRNA-1405 Dose Level 3Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.

Group VII: Phase 1 Part: mRNA-1405 Dose Level 2Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.

Group VIII: Phase 1 Part: mRNA-1405 Dose Level 1Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.

Group IX: Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 2Experimental Treatment2 Interventions

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.

Group X: Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 1Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.

Group XI: Phase 1 Part: mRNA-1403 Dose Level 3Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.

Group XII: Phase 1 Part: mRNA-1403 Dose Level 2Experimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.

Group XIII: Phase 1 Part: mRNA-1403 Dose Level 1Experimental Treatment1 Intervention

Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.

Group XIV: Phase 1 Part: PlaceboPlacebo Group1 Intervention

Participants will receive 2 IM injections of study vaccine-matching placebo.

Group XV: Phase 2 Part: PlaceboPlacebo Group1 Intervention

Participants will receive 1 IM injection of study vaccine-matching placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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

mRNA-based vaccines, such as mRNA-1403 and mRNA-1405, work by delivering messenger RNA (mRNA) into the body's cells, instructing them to produce a protein that is part of the Norovirus. This protein triggers the immune system to recognize and combat the actual virus if the person is exposed in the future. This mechanism is significant for Norovirus patients as it can help prevent infection or lessen the severity of symptoms, providing a proactive approach to managing the disease.

Molecular Mechanisms of Merkel Cell Polyomavirus Transformation and Replication.Modeling oncolytic virus dynamics in the tumor microenvironment using zebrafish.The possible of immunotherapy for COVID-19: A systematic review.