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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04144348
Other study ID # mRNA-1653-P102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 4, 2019
Est. completion date December 20, 2022

Study information

Verified date January 2023
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
mRNA-1653
Sterile liquid for injection
Placebo
Sterile liquid for injection

Locations

Country Name City State
United States UHS Primary Care Binghamton New York
United States Central Research Associates Inc Birmingham Alabama
United States Crossroads Clinical Research Corpus Christi Texas
United States Ohio Pediatric Research Assn Inc Dayton Ohio
United States Duke Vaccine and Trials Unit Durham North Carolina
United States Heartland Research Associates LLC El Dorado Kansas
United States University of Texas Medical Branch (UTMB) Galveston Texas
United States Clinical Research Prime Idaho Falls Idaho
United States Tanner Clinic Layton Utah
United States Meridian Clinical Research, LLC Lincoln Nebraska
United States Child Healthcare Associates Liverpool New York
United States MedPharmics Metairie Louisiana
United States Heartland Research Associates LLC Newton Kansas
United States Meridian Clinical Research Norfolk Nebraska
United States Meridian Clinical Research, LLC Omaha Nebraska
United States Tekton Research Inc San Antonio Texas
United States Sanford Children's Hospital Sioux Falls South Dakota
United States Child Healthcare Assoc. Syracuse New York
United States Meridian Clinical Research Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to 7 days after each dose administration
Primary Proportion of Participants with Unsolicited Adverse Events (AEs) Up to 28 days after each dose administration
Primary Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs Up to 1 year after the last dose administration
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03392389 - Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults Phase 1