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Virus Therapy

mRNA Vaccines for Norovirus

Phase 1 & 2
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial tests the safety and immune response of two experimental mRNA vaccines, mRNA-1403 and mRNA-1405, in healthy adults. The vaccines help the body learn to fight a virus by giving it a practice run without causing illness.

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.
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.
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 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
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

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
121 Previous Clinical Trials
66,783,789 Total Patients Enrolled

Media Library

mRNA-1403 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05992935 — Phase 1 & 2
Norovirus Research Study Groups: Phase 2 Part: mRNA-1403 Dose Level 1, Phase 2 Part: mRNA-1403 Dose Level 3, Phase 1 Part: mRNA-1405 Dose Level 3, Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 2, Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 2, Phase 1 Part: Placebo, Phase 1 Part: mRNA-1405 Dose Level 2, Phase 2 Part: mRNA-1403 Dose Level 2, Phase 1 Part: mRNA-1403 Dose Level 1, Phase 1 Part: mRNA-1405 Dose Level 1, Phase 1 Part: mRNA-1403 Dose Level 2, Phase 1 Part: mRNA-1403 Dose Level 3, Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 1, Phase 2 Part: Placebo, Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 1
Norovirus Clinical Trial 2023: mRNA-1403 Highlights & Side Effects. Trial Name: NCT05992935 — Phase 1 & 2
mRNA-1403 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05992935 — Phase 1 & 2
~203 spots leftby Apr 2025