mRNA-1403 for Stomach Flu

(Nova 301 Trial)

Recruiting at 311 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Blood products

Disqualifiers: Chronic GI disease, Immunodeficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

28000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1403, to determine if it can safely and effectively prevent moderate to severe stomach flu caused by norovirus. Participants will receive either the actual vaccine or a placebo (a harmless substance with no therapeutic effect) through a single injection. The trial targets individuals who are generally healthy but may have stable chronic conditions and have not recently experienced stomach flu or close contact with someone who has. Those with stable chronic conditions without ongoing symptoms like regular vomiting or diarrhea might be suitable candidates. As a Phase 3 trial, this is the final step before FDA approval, offering participants the chance to contribute to a potentially groundbreaking vaccine.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapies or have received certain vaccines recently, you may need to discuss this with the study team.

Is there any evidence suggesting that mRNA-1403 is likely to be safe for humans?

Research has shown that mRNA-1403 is generally safe and well-tolerated. In earlier studies, individuals of all ages, both young and old, received this treatment without major issues. The treatment also triggered specific immune responses, a positive sign. These results suggest that the vaccine is safe for most people, though, like any new treatment, it might have side effects. Those with a history of adverse reactions to vaccines should consider this. Overall, the evidence supports its safety for use in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike current treatments for stomach flu, which typically focus on managing symptoms with rehydration solutions and anti-nausea medications, mRNA-1403 introduces a novel approach by utilizing messenger RNA technology. Researchers are excited about mRNA-1403 because it works by instructing cells to produce proteins that may help the immune system effectively target and combat the virus causing the stomach flu. This innovative mechanism of action has the potential to provide a more direct and efficient response to the infection, offering a promising new avenue for treating this common and often disruptive condition.

What evidence suggests that mRNA-1403 might be an effective treatment for stomach flu?

Research shows that the mRNA-1403 vaccine is under development to prevent norovirus, a common cause of stomach flu. In this trial, participants will receive either a single injection of mRNA-1403 or a placebo. One study found that a similar vaccine for norovirus was 85% effective in preventing stomach and intestinal inflammation. This suggests that mRNA-1403 could significantly reduce the risk of moderate or severe stomach flu from norovirus. Although more information is needed, positive results from earlier research strongly support the potential of this vaccine. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who want to prevent severe stomach flu caused by norovirus. Participants should be healthy with no recent history of gastroenteritis and not pregnant. They can't join if they've had a bad reaction to vaccines before or are on medications that affect the immune system.

Inclusion Criteria

I can sign the consent form and follow the study's requirements.

I understand the study requirements and can follow them on my own.

Participants may have chronic medical diagnoses but should be medically stable as assessed by the following criteria: Absence of medical events associated with underlying diagnoses and qualifying as SAEs within 1 month prior to study intervention on Day 1. Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the study and which, in the opinion of the Investigator, would make completion of the protocol unlikely.

Exclusion Criteria

Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius (°C) [100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.

History of a diagnosis or condition that in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.

Reported 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of mRNA-1403 or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1403

Trial Overview The study tests mRNA-1403, which is a new vaccine aimed at preventing acute gastroenteritis from norovirus. Some participants will receive the actual vaccine while others will get a placebo, and researchers will compare results between these two groups.

How Is the Trial Designed?

Group I: mRNA-1403 Experimental Treatment 1 Intervention

Participants will receive a single injection of mRNA-1403 on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.

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/PMC12350415/

The Impact of Norovirus on Children and Adolescents 1 Norwalk virus VP1 gene, the observed vaccine efficacy, 29% against infection and 21% against gastroenteritis, was low. However, the 85% ...

2. 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 ...

3. nihr.ac.uk nihr.ac.uk/news/uks-first-norovirus-mrna-vaccine-trial-launched

UK's first norovirus mRNA vaccine trial launched The first Phase 3 randomised clinical trial of an investigational mRNA norovirus vaccine will open across the UK within the next two weeks.

4. contagionlive.com contagionlive.com/view/fda-places-hold-on-moderna-s-norovirus-vaccine-over-a-single-case-of-guillain-barr-syndrome

FDA Places Hold on Moderna's Norovirus Vaccine Over a ... The company disclosed their investigational norovirus trivalent vaccine (mRNA-1403) was placed on hold by the FDA after a case of Guillain-Barré syndrome was ...

5. 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 to ...

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

575. Safety and Immunogenicity of mRNA-1403, a ... mRNA-1403 was generally safe and well-tolerated, and induced antigen-specific immune responses at all dose levels in both younger and older healthy adults.

7. 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.

8. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1403%2F1405-P101

A Clinical Trial of a Norovirus Vaccine for Adults Over 18 The NOVA Trial is a Phase 2 clinical trial being conducted by Moderna to evaluate the safety and immune response of a messenger RNA (mRNA)-based ...

9. withpower.com withpower.com/trial/phase-3-acute-gastroenteritis-8-2024-e198f

mRNA-1403 for Stomach Flu · Info for Participants Participants should be healthy with no recent history of gastroenteritis and not pregnant. They can't join if they've had a bad reaction to vaccines before or ...