Clinical trial NCT04144348: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Metapneumovirus and Human Parainfluenza Infection
Keywords: ModernaTX
mRNA-1653
human metapneumovirus
human parainfluenza
human parainfluenza vaccine
virus diseases
RNA virus infections
paramyxoviridae infections
mononegavirales infections
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to 7 days after each dose administration
measure: Proportion of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to 28 days after each dose administration
measure: Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
timeFrame: Up to 1 year after the last dose administration
Secondary outcomes:
measure: Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
timeFrame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
measure: Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
timeFrame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
measure: Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline
timeFrame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates Inc
state: Alabama
city: Washington
country: United States
facility: Meridian Clinical Research
state: District of Columbia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: El Dorado
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Lincoln
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Binghamton
country: United States
facility: UHS Primary Care
state: New York
city: Liverpool
country: United States
facility: Child Healthcare Associates
state: New York
city: Syracuse
country: United States
facility: Child Healthcare Assoc.
state: New York
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research Assn Inc
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Children's Hospital
state: South Dakota
city: Corpus Christi
country: United States
facility: Crossroads Clinical Research
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB)
state: Texas
city: San Antonio
country: United States
facility: Tekton Research Inc
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
References: