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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Human Metapneumovirus and Human Parainfluenza Infection
• Intervention / Treatment: Biological: mRNA-1653; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates Inc
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Meridian Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Heartland Research Associates LLC
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research, LLC
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • New York
    • Binghamton, New York, United States, 13901
      • UHS Primary Care
    • Liverpool, New York, United States, 13090
      • Child Healthcare Associates
    • Syracuse, New York, United States, 13057
      • Child Healthcare Assoc.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Vaccine and Trials Unit
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Assn Inc
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford Children's Hospital
  • Texas
    • Corpus Christi, Texas, United States, 78413
      • Crossroads Clinical Research
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch (UTMB)
    • San Antonio, Texas, United States, 78240
      • Tekton Research Inc
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: mRNA-1653; Sterile liquid for injection
Experimental: mRNA-1653 Pediatric participants; Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.	Biological: mRNA-1653; Sterile liquid for injection
Placebo Comparator: Placebo, Adult participants; Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.	Biological: Placebo; Sterile liquid for injection; Other Names: saline
Placebo Comparator: Placebo, Pediatric participants; Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.	Biological: Placebo; Sterile liquid for injection; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: virus diseases; ModernaTX; mRNA-1653; human metapneumovirus; human parainfluenza; human parainfluenza vaccine; RNA virus infections; paramyxoviridae infections; mononegavirales infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Mononegavirales Infections; Infections; Paramyxoviridae Infections
• Other Study ID Numbers: mRNA-1653-P102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No