mRNA Vaccines for Norovirus

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

1285 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the mRNA-1403 and mRNA-1405 treatment for norovirus different from other treatments?

The mRNA-1403 and mRNA-1405 treatments are unique because they use mRNA technology, which instructs cells to produce a protein that triggers an immune response, unlike traditional vaccines that often use weakened or inactivated viruses. This approach is novel for norovirus, as there are currently no standard vaccines available for this condition. ^{1 2 3 4 5}

Eligibility Criteria

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

Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an oral suspension of VP20621, spores of nontoxigenic Clostridium difficile strain M3, in healthy subjects. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of the Safety and Efficacy of Vaccines as Prophylaxis for Clostridium difficile Infections. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Replicating Single-Cycle Adenovirus Vaccine Effective against Clostridium difficile. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clostridium difficile vaccine and serum immunoglobulin G antibody response to toxin A. [2021]