mRNA-1653 Vaccine for Viral Infections

No longer recruiting at 20 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Acute illness, Chronic illness, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and immune response of a new vaccine, mRNA-1653, which targets two viruses: human metapneumovirus (a virus causing respiratory infections) and parainfluenza virus type 3. It involves two groups: healthy adults and young children previously exposed to these viruses. Participants will receive either the actual vaccine or a placebo (a harmless substance used for comparison). Eligible participants include healthy adults and children who have had previous exposure to these viruses and are up to date with routine vaccinations. 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 vaccine.

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.

Is there any evidence suggesting that mRNA-1653 is likely to be safe for humans?

Earlier studies found mRNA-1653 to be safe for both adults and children. Research shows that healthy adults who received the vaccine had a good safety record and produced more antibodies, which help fight viruses. Similarly, children aged 12 to 59 months who received the vaccine tolerated it well and showed increased antibody levels.

Current evidence suggests that mRNA-1653 is safe for people, based on existing knowledge. Although these studies remain in the early stages, the positive safety results are promising for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about mRNA-1653 because it represents a novel approach to combating both human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) with a single vaccine. Unlike traditional vaccines, which often use weakened or inactivated viruses, mRNA-1653 uses messenger RNA to instruct cells to produce proteins that trigger an immune response. This method could potentially offer a more efficient and faster way to boost immunity against these viruses. Additionally, the use of mRNA technology, which has shown great promise in recent vaccines, might result in improved safety and efficacy compared to older methods.

What evidence suggests that mRNA-1653 could be an effective treatment for human metapneumovirus and human parainfluenza virus type 3?

Research has shown that the mRNA-1653 vaccine, which participants in this trial may receive, could strengthen the immune system against two viruses: human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3). Studies found that most people tolerated the vaccine well, indicating its safety. Importantly, the vaccine increased the body's defenses against these viruses—by about six times for hMPV and three times for PIV3, compared to before vaccination. This suggests the vaccine could help the immune system fight off these viruses more effectively. Early results indicate that mRNA-1653 could be a useful tool in preventing these infections. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1653

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9251669/

Safety and Immunogenicity of an mRNA-Based Human ... mRNA-1653 was well tolerated, with an acceptable safety profile and increased hMPV and PIV3 neutralization titers in healthy adults.

2. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1653-P102

Trial Details Page, ID: mRNA-1653-P102 This study is evaluating an investigational combination vaccine, called mRNA-1653, to protect against hMPV and PIV3.

3. academic.oup.com academic.oup.com/ofid/article/10/Supplement_2/ofad500.2266/7446658

2655. Phase 1 Safety and Immunogenicity Results of Two ... Interim data through Month (M) 5 for mRNA-1345 and M3 for mRNA-1653 are reported. Results. mRNA-1345 and mRNA-1653 were well-tolerated. The ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04144348?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Parainfluenza%20vaccine)))&rank=6

Study Details | Safety and Immunogenicity of mRNA-1653, ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

5. s29.q4cdn.com s29.q4cdn.com/435878511/files/doc_downloads/program_detail/respiratory/hMPV_PIV3-(02-24-22).pdf

hMPV/PIV3 vaccine (mRNA-1653) - Moderna Presentation Phase 1 study (hMPV and PIV3 neutralization titers were boosted ~6X and ~3X baseline, respectively). ▫ Recent interim data also show that mRNA- ...

6. publications.aap.org publications.aap.org/pediatrics/article/153/6/e2023064748/197265/Safety-and-Immunogenicity-of-an-mRNA-Based-hMPV

Safety and Immunogenicity of an mRNA-Based hMPV/PIV3 ... mRNA-1653 was well-tolerated and boosted hMPV and PIV3 antibody levels in seropositive children aged 12 to 59 months.

7. fda.gov fda.gov/media/184378/download

Moderna Final Data Reviewed on 8-23 Month Olds Prior to Enrollment of 5-7 Month Olds. Safety data after complete RSV season in. Panama & US. Unblinded review.