Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 : October 5, 2021
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 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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
Masking: Triple (Participant, Care Provider, 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 to 59 Months of Age With Serologic Evidence of Prior Exposure
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


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 3 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 Name: 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 Name: saline




Primary Outcome Measures :
  1. Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: up to 7 days after each dose administration ]
  2. Proportion of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: up to 28 days after each dose administration ]
  3. Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs [ Time Frame: Up to 1 year after the last dose administration ]

Secondary Outcome Measures :
  1. Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies [ Time Frame: Day 29, 57, 85, and 224, for adults; Day 29 and 85, for pediatric participants ]
  2. Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies [ Time Frame: Day 29, 57, 85, and 224, for adults; Day 29 and 85, for pediatric participants ]
  3. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Layout table for location contacts
Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
ModernaTX, Inc.
Layout table for additonal information
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: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases