Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure

Recruiting at 19 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine that helps the body fight off two types of respiratory viruses. It will be tested on healthy adults and young children who have been exposed to these viruses before. The vaccine works by teaching the body to recognize and combat these viruses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on any chronic immunosuppressant or immune-modifying drugs.

What safety data exists for mRNA-1653 or similar treatments?

Antisense oligonucleotides (ASOs), which are similar to mRNA-1653, have been tested in human clinical trials and shown to be generally safe, though some mild side effects like low platelet count, high blood sugar, and low blood pressure have been noted. These side effects are usually mild and can be treated with standard medications. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

schedule The individual has received the necessary vaccines as advised by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).

Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if they meet all of the following criteria: 1) they have a negative pregnancy test at Screening and on the day of vaccination, 2) they have practiced adequate contraception or have abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, 3) they have agreed to continue adequate contraception through 3 months following the last vaccination, and 4) they are not currently breastfeeding.

You have a body mass index (BMI) of at least 18 and less than 35.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 of 2 doses of mRNA-1653 or placebo, administered via intramuscular injection on Day 1 and Day 57

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after treatment

4 weeks

Treatment Details

Interventions

• mRNA-1653

Participant Groups

Group I: mRNA-1653, Adult participants Experimental Treatment 1 Intervention

Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.

Group II: mRNA-1653 Pediatric participants Experimental Treatment 1 Intervention

Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.

Group III: Placebo, Adult participants Placebo Group 1 Intervention

Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.

Group IV: Placebo, Pediatric participants Placebo Group 1 Intervention

Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.

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. Netherlands pubmed.ncbi.nlm.nih.gov

Antisense oligonucleotide splicing modulation as a novel Cystic Fibrosis therapeutic approach for the W1282X nonsense mutation. [2022]

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

Oligo safety working group exaggerated pharmacology subcommittee consensus document. [2016]

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

Toxicology of antisense therapeutics. [2012]

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

Molecular profiling of individual FDA-approved clinical drugs identifies modulators of nonsense-mediated mRNA decay. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Readthrough compounds for nonsense mutations: bridging the translational gap. [2023]