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
A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
1 other identifier
interventional
51
1 country
19
Brief Summary
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 2 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2019
Typical duration for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2022
CompletedFebruary 3, 2023
January 1, 2023
3.1 years
October 28, 2019
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to 7 days after each dose administration
Proportion of Participants with Unsolicited Adverse Events (AEs)
Up to 28 days after each dose administration
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Up to 1 year after the last dose administration
Secondary Outcomes (3)
Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline
Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Study Arms (4)
mRNA-1653, Adult participants
EXPERIMENTALParticipants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
mRNA-1653 Pediatric participants
EXPERIMENTALParticipants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
Placebo, Adult participants
PLACEBO COMPARATORParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Placebo, Pediatric participants
PLACEBO COMPARATORParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (19)
Central Research Associates Inc
Birmingham, Alabama, 35205, United States
Meridian Clinical Research
Washington D.C., District of Columbia, 20016, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Heartland Research Associates LLC
El Dorado, Kansas, 67042, United States
Heartland Research Associates LLC
Newton, Kansas, 67114, United States
MedPharmics
Metairie, Louisiana, 70006, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, 68510, United States
Meridian Clinical Research
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
UHS Primary Care
Binghamton, New York, 13901, United States
Child Healthcare Associates
Liverpool, New York, 13090, United States
Child Healthcare Assoc.
Syracuse, New York, 13057, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27710, United States
Ohio Pediatric Research Assn Inc
Dayton, Ohio, 45414, United States
Sanford Children's Hospital
Sioux Falls, South Dakota, 57117, United States
Crossroads Clinical Research
Corpus Christi, Texas, 78413, United States
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555, United States
Tekton Research Inc
San Antonio, Texas, 78240, United States
Tanner Clinic
Layton, Utah, 84041, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Observer blind
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
November 4, 2019
Primary Completion
December 20, 2022
Study Completion
December 20, 2022
Last Updated
February 3, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share