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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04144348

Collaborator

(none)

Enrollment

Locations

Arms

40.8

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric CohortParallel 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 :

Nov 4, 2019

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Research Associates Inc	Birmingham	Alabama	United States	35205
2	Meridian Clinical Research	Washington	District of Columbia	United States	20016
3	Clinical Research Prime	Idaho Falls	Idaho	United States	83404
4	Heartland Research Associates LLC	El Dorado	Kansas	United States	67042
5	Heartland Research Associates LLC	Newton	Kansas	United States	67114
6	MedPharmics	Metairie	Louisiana	United States	70006
7	Meridian Clinical Research, LLC	Lincoln	Nebraska	United States	68510
8	Meridian Clinical Research	Norfolk	Nebraska	United States	68701
9	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
10	UHS Primary Care	Binghamton	New York	United States	13901
11	Child Healthcare Associates	Liverpool	New York	United States	13090
12	Child Healthcare Assoc.	Syracuse	New York	United States	13057
13	SUNY Upstate Medical Center	Syracuse	New York	United States	13210
14	Duke Vaccine and Trials Unit	Durham	North Carolina	United States	27710
15	Ohio Pediatric Research Assn Inc	Dayton	Ohio	United States	45414
16	Sanford Children's Hospital	Sioux Falls	South Dakota	United States	57117
17	Crossroads Clinical Research	Corpus Christi	Texas	United States	78413
18	University of Texas Medical Branch (UTMB)	Galveston	Texas	United States	77555
19	Tekton Research Inc	San Antonio	Texas	United States	78240
20	Tanner Clinic	Layton	Utah	United States	84041