mRNA Vaccines for Norovirus

Not currently recruiting at 17 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Systemic corticosteroids

Disqualifiers: Immunosuppressive condition, Myocarditis, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new mRNA vaccines for safety and effectiveness in protecting against norovirus, a common virus causing stomach issues. Participants will receive varying doses of the vaccines, mRNA-1403 or mRNA-1405, or a placebo for comparison. The trial is open to healthy adults without a history of serious vaccine reactions or immune system conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapies, you may not be eligible. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mRNA-1403 is generally safe and well-tolerated. In earlier studies, participants did not experience major safety issues, and the treatment was accepted without significant problems. While less safety information exists for mRNA-1405, early results suggest it is also well-tolerated.

Both mRNA-1403 and mRNA-1405 are being tested for their ability to trigger an immune response, indicating that the body is responding correctly to the treatment. Since the trials are in the early stages, less is known about long-term effects, but serious safety concerns are less likely to have been reported.

These findings come from earlier studies. New data from ongoing trials will provide more information about safety. This trial is an important step in understanding how these treatments work in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for norovirus, which typically focus on managing symptoms like dehydration and nausea, the mRNA vaccines mRNA-1403 and mRNA-1405 offer a proactive approach by aiming to prevent infection altogether. These vaccines utilize mRNA technology, which teaches the body to recognize and fight the virus by producing a harmless piece of the virus's protein. This is a novel mechanism compared to the standard of care, which lacks specific antiviral treatments for norovirus. Researchers are excited because mRNA vaccines can potentially provide targeted immunity and be developed more rapidly than traditional vaccines, offering a promising new way to combat norovirus outbreaks.

What evidence suggests that this trial's treatments could be effective for norovirus?

Research shows that mRNA-1403 and mRNA-1405 are being developed as vaccines to prevent norovirus, a common cause of stomach flu. In this trial, participants will receive either mRNA-1403 or mRNA-1405 at various dose levels to evaluate their safety and effectiveness. Studies have found that mRNA-1403 is generally safe and helps the immune system fight norovirus. Early results also indicate that it is well-tolerated, meaning it doesn’t cause serious side effects. Meanwhile, mRNA-1405 is being developed to prevent stomach problems caused by norovirus. The mRNA technology used in these vaccines has succeeded in other vaccines, suggesting these could work well too. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A person of childbearing potential is using a highly effective contraceptive method

Participant has provided written informed consent for participation in this study

I am not pregnant or breastfeeding.

Exclusion Criteria

I have a bleeding disorder that makes injections or blood draws unsafe.

History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine

I have had myocarditis or pericarditis in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive mRNA-1403 or mRNA-1405 at various dose levels to evaluate safety, reactogenicity, and immunogenicity

6-8 weeks

2-3 visits (in-person)

Phase 2 Treatment

Participants receive mRNA-1403 at various dose levels to evaluate safety, reactogenicity, and immunogenicity

6-8 weeks

1-2 visits (in-person)

Booster Extension (optional)

Participants may receive a booster dose of mRNA-1403 or placebo 12-15 months after the first dose

12-15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1403
• mRNA-1405
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Phase 2 Part: mRNA-1403 Dose Level 3 Experimental Treatment 2 Interventions

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 or study vaccine-matching placebo 12-15 months after first dose.

Group II: Phase 2 Part: mRNA-1403 Dose Level 2 Experimental Treatment 2 Interventions

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 or study vaccine-matching placebo 12-15 months after first dose.

Group III: Phase 2 Part: mRNA-1403 Dose Level 1 Experimental Treatment 1 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 2 Experimental Treatment 2 Interventions

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

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

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

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

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

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

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

Group VIII: Phase 1 Part: mRNA-1405 Dose Level 1 Experimental Treatment 1 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 2 Experimental Treatment 2 Interventions

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

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

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

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

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

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

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

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

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

Group XIV: Phase 1 Part: Placebo Placebo Group 1 Intervention

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

Group XV: Phase 2 Part: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11776675/

575. Safety and Immunogenicity of mRNA-1403, a ...

Available data from this ongoing Phase 1/2 study show that mRNA-1403 was generally safe and well-tolerated, and induced antigen-specific immune ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12350415/

The Impact of Norovirus on Children and Adolescents

The results of this study will provide critical insights into the efficacy of an mRNA-based approach to norovirus vaccination, particularly ...

3.

clinicaltrialsarena.com

clinicaltrialsarena.com/analyst-comment/idweek-2024-moderna-norovirus-vaccine/

IDWeek 2024: Moderna's norovirus vaccine mRNA-1403 ...

The interim results for safety, reactogenicity, and immunogenicity appear to be promising. No major safety concerns were identified for mRNA- ...

4.

cdn.who.int

cdn.who.int/media/docs/default-source/immunization/pdvac/pdvac-2024/day-3/norovirus-vaccines.pdf

Norovirus Vaccine Pipeline

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 ...

5.

trials.modernatx.com

trials.modernatx.com/study/?id=mRNA-1403-P301

A Clinical Trial of a Norovirus Vaccine for Adults

The Nova 301 Trial will evaluate the safety, effectiveness, and immune response of an investigational vaccine, called mRNA-1403, aimed at preventing norovirus ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05992935

NCT05992935 | Study to Evaluate the Safety, ...

The purpose of the Phase 2 Part of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants 18 to 80 ...

7.

s29.q4cdn.com

s29.q4cdn.com/435878511/files/doc_presentations/2024/Oct/19/NoroPh12-IDweek24-Oct15.pdf

Safety and Immunogenicity of mRNA-1403, a Multivalent ...

Safety and Immunogenicity of mRNA-1403, a. Multivalent Norovirus mRNA Vaccine in Healthy Adults: Interim Results of a Phase 1/2, Randomized ...

8.

vaccineadvisor.com

vaccineadvisor.com/news/moderna-provides-update-on-norovirus-vaccine-candidate/

Moderna Provides Update on Norovirus Vaccine Candidate

Moderna's mRNA-1403 is a messenger RNA-based trivalent vaccine candidate designed to protect against multiple norovirus genotypes.