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

Study Purpose

This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 3 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Months - 49 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination.
  • - Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
  • - Screening laboratory values Grade ≤1.
Specific inclusion criteria for adults 18 to 49 years of age:
  • - Body mass index (BMI) from ≥18 kg/m^2 and ≤35 kg/m^2.
  • - Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding.
Specific inclusion criteria for children 12 to 59 months of age:
  • - Seropositive for both hMPV and PIV3 neutralizing antibody at Screening.
  • - Has received routine immunizations appropriate for age per the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) - Current height and weight above the third percentile for age.
Key

Exclusion Criteria:

Adult and pediatric participants eligible for this study must not meet any of the following criteria:
  • - Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination.
  • - Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
  • - Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection.
The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
  • - Any chronic administration of an immunosuppressant or other immune modifying drug.
  • - Prior administration of investigational agent using lipid nanoparticle formulations.
  • - Donation of blood or blood products ≥450 mL within 28 days of the Screening visit (for the Adult Cohort) - Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.
  • - Participated in an interventional clinical trial within 28 days prior to the day of enrollment, or plans to do so while enrolled in this trial.
- Has a family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04144348
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Human Metapneumovirus and Human Parainfluenza Infection
Arms & Interventions

Arms

Experimental: mRNA-1653, Adult participants

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

Experimental: mRNA-1653 Pediatric participants

Participants will receive 1 of 3 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.

Placebo Comparator: Placebo, Adult participants

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

Placebo Comparator: Placebo, Pediatric participants

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

Interventions

Biological: - mRNA-1653

sterile liquid for injection

Biological: - Placebo

sterile liquid for injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.

Central Research Associates Inc
Recruiting | Birmingham, Alabama, United States, 35205
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Clinical Research Prime
Not yet recruiting | Idaho Falls, Idaho, United States, 83404
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Heartland Research Associates LLC
Recruiting | El Dorado, Kansas, United States, 67042
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Heartland Research Associates LLC
Recruiting | Newton, Kansas, United States, 67114
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MedPharmics
Recruiting | Metairie, Louisiana, United States, 70006
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Meridian Clinical Research
Recruiting | Norfolk, Nebraska, United States, 68701
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Meridian Clinical Research, LLC
Recruiting | Omaha, Nebraska, United States, 68134
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Meridian Clinical Research
Recruiting | Binghamton, New York, United States, 13901
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Child Healthcare Associates
Recruiting | Liverpool, New York, United States, 13090
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Child Healthcare Assoc.
Recruiting | Syracuse, New York, United States, 13057
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Duke Vaccine and Trials Unit
Not yet recruiting | Durham, North Carolina, United States, 27710
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Ohio Pediatric Research Assn Inc
Recruiting | Dayton, Ohio, United States, 45414
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Sanford Children's Hospital
Recruiting | Sioux Falls, South Dakota, United States, 57105
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Crossroads Clinical Research
Recruiting | Corpus Christi, Texas, United States, 78413
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University of Texas Medical Branch (UTMB)
Recruiting | Galveston, Texas, United States, 77555
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Tekton Research Inc
Recruiting | San Antonio, Texas, United States, 78240
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Tanner Clinic
Recruiting | Layton, Utah, United States, 84041
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