← Back to Search

Virus Therapy

mRNA Vaccines for Norovirus

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
Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest/body feeding
Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through 6 months after last study intervention (day 169)
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant or breastfeeding.
Select...
I am either 18-49 or 60-80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 6 months after last study intervention (day 169)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 6 months after last study intervention (day 169) 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 SAEs, AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and 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 Titers
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers
+3 more

Trial Design

11Treatment groups
Experimental Treatment
Placebo Group
Group I: 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 II: mRNA-1405 Dose Level 4 Regimen 1Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
Group III: mRNA-1405 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
Group IV: mRNA-1405 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
Group V: mRNA-1405 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
Group VI: 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 VII: mRNA-1403 Dose Level 4 Regimen 1Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
Group VIII: mRNA-1403 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
Group IX: mRNA-1403 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
Group X: mRNA-1403 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
Group XI: PlaceboPlacebo Group1 Intervention
Participants will receive 2 IM injections of study vaccine-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,461 Total Patients Enrolled

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research permit participation from those who are aged fifty or more?

"According to the trial's parameters, potential participants must be between 18 and 80 years old."

Answered by AI

What are the eligibility requirements for participating in this trial?

"This study is open to applicants aged 18-80 who have been diagnosed with norovirus, and it will recruit up to 660 participants."

Answered by AI

Are opportunities currently available for individuals to participate in this clinical trial?

"The information published on clinicaltrials.gov attests that this particular trial is not currently accepting applicants, despite having been posted on August 25th 2023 and last updated 8 days later. Despite this, 22 alternative medical studies are still recruiting participants at the present time."

Answered by AI

Is this scientific trial being conducted at multiple sites across the United States?

"Several clinics are participating in this trial, such as Tekton Research Inc.'s Longmont Center and Research Centers of America's Hollywood branch. The Accel Research Sites Network also has a facility located in Decatur that is enrolling patients. In total, 15 locations are taking part in the study."

Answered by AI

To what extent do individuals risk exposure to harm at mRNA-1405 Dose Level 2?

"mRNA-1405 Dose Level 2's safety has been assessed as a 1, given its status in the Phase 1 trial structure implies that there is sparse evidence verifying both efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
ARK Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~310 spots leftby Dec 2024