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Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12-36 Months of Age With Serologic Evidence of Prior Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144348
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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 (18-49 years of age) and 3 dose levels in children (12-36 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.

Condition or disease Intervention/treatment Phase
Human Metapneumovirus and Human Parainfluenza Infection Biological: mRNA-1653 Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
Masking: Double (Participant, Investigator)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: 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 12-36 Months of Age With Serologic Evidence of Prior Exposure
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-1653, Adult participants Biological: mRNA-1653
Experimental vaccine

Biological: Placebo
Saline

Experimental: mRNA-1653 Pediatric participants Biological: mRNA-1653
Experimental vaccine

Biological: Placebo
Saline




Primary Outcome Measures :
  1. Frequency of solicited local and systemic adverse reactions (ARs) [ Time Frame: 7 days following each dose administration ]
  2. Frequency of unsolicited adverse events (AEs) [ Time Frame: 28 days following each dose administration ]
  3. Frequency of serious adverse events (SAEs) and medically-attended AEs [ Time Frame: One year following the last dose administration ]

Secondary Outcome Measures :
  1. Geometric mean titer (GMT) of serum anti-hMPV and anti-PIV3 neutralizing antibodies, and geometric mean ratio (GMR) of post-baseline/baseline titers. [ Time Frame: Day 29, 57, 85 and 224, for adults; Day 29 and 85, for pediatric participants ]
  2. Proportion of participants with ≥ 2-fold and ≥ 4-fold increases in serum anti-hMPV or anti-PIV3 neutralizing antibody titer from baseline [ Time Frame: Day 29, 57, 85 and 224, for adults; Day 29 and 85, for pediatric participants ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18-49 years of age and children 12-36 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 18-49 years of age:

  • body mass index (BMI) from ≥ 18 kg/m2 and ≤ 35 kg/m2
  • 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 12-36 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

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) within 14 days prior to first vaccination, or plans to receive through 14 days following the last study vaccination, or a live virus vaccine(s) within 28 days prior to first vaccination, or plans to receive through 28 days following the last study vaccination.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144348


Contacts
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Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
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United States, Alabama
Central Research Associates Inc Recruiting
Birmingham, Alabama, United States, 35205
United States, Idaho
Clinical Research Prime Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Kansas
Heartland Research Associates LLC Recruiting
El Dorado, Kansas, United States, 67042
Heartland Research Associates LLC Recruiting
Newton, Kansas, United States, 67114
United States, Louisiana
MedPharmics Recruiting
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Clinical Research Recruiting
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research, LLC Recruiting
Omaha, Nebraska, United States, 68134
United States, New York
Meridian Clinical Research Recruiting
Binghamton, New York, United States, 13901
Child Healthcare Associates Not yet recruiting
Liverpool, New York, United States, 13090
Child Healthcare Assoc. Not yet recruiting
Syracuse, New York, United States, 13057
United States, North Carolina
Duke Vaccine and Trials Unit Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio Pediatric Research Assn Inc Recruiting
Dayton, Ohio, United States, 45414
United States, South Dakota
Sanford Children's Hospital Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Crossroads Clinical Research Recruiting
Corpus Christi, Texas, United States, 78413
University of Texas Medical Branch (UTMB) Recruiting
Galveston, Texas, United States, 77555
Tekton Research Inc Recruiting
San Antonio, Texas, United States, 78240
United States, Utah
Tanner Clinic Recruiting
Layton, Utah, United States, 84041
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04144348    
Other Study ID Numbers: mRNA-1653-P102
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
ModernaTX
mRNA-1653
human metapneumovirus
human parainfluenza
human parainfluenza vaccine
virus diseases
RNA virus infections
paramyxoviridae infections
mononegavirales infections
Additional relevant MeSH terms:
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Infection
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases