Your session is about to expire
← 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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through 6 months after last study intervention (day 169)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 6 months after last study intervention (day 169)
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 moreSecondary 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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that makes injections or blood draws unsafe.I have had myocarditis or pericarditis in the past.I have an immune condition or HIV that requires immunosuppressive treatment.I have not received any blood products or immunoglobulins in the last 3 months.I have not received vaccines, except flu shots, close to my treatment dates.I have not been feverish or severely ill in the last 72 hours.I haven't taken strong immune system suppressing drugs for more than 2 weeks in the last 6 months.I am not pregnant or breastfeeding.I am either 18-49 or 60-80 years old.I have not donated more than 450 mL of blood in the last 28 days and do not plan to donate during the study.I have not been in a drug study in the last 28 days and don't plan to join another while in this study.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1403 Dose Level 4 Regimen 2
- Group 2: mRNA-1405 Dose Level 4 Regimen 2
- Group 3: mRNA-1405 Dose Level 2
- Group 4: mRNA-1405 Dose Level 3
- Group 5: mRNA-1405 Dose Level 4 Regimen 1
- Group 6: Placebo
- Group 7: mRNA-1403 Dose Level 1
- Group 8: mRNA-1403 Dose Level 2
- Group 9: mRNA-1403 Dose Level 3
- Group 10: mRNA-1403 Dose Level 4 Regimen 1
- Group 11: mRNA-1405 Dose Level 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger