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mRNA-1653

Phase 1

Human Metapneumovirus and Human Parainfluenza Infection | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Feb 3, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment175
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04144348Safety 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 ExposurePHASE1 COMPLETED 51 — — Nov 4, 2019Dec 20, 2022Feb 3, 202319 United States
NCT03392389Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy AdultsPHASE1 COMPLETED 124 — — Dec 4, 2017Jul 29, 2019Feb 6, 20203 United States
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Study Endpoints
Primary Endpoints
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
Frequency of solicited AEs (local and systemic reactogenicity events)
7 days following each dose administration
Frequency of unsolicited adverse events
28 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs
one year following the last dose administration
Frequency of clinical laboratory adverse events
1 month following the last dose administration
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
1 month following the last dose administration
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
1 month following the last dose administration
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline
1 month following the last dose administration
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1653, Adult participantsEXPERIMENTALParticipants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
mRNA-1653 Pediatric participantsEXPERIMENTALParticipants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
Placebo, Adult participantsPLACEBO_COMPARATORParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Placebo, Pediatric participantsPLACEBO_COMPARATORParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
mRNA-1653EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
mRNA-1653BIOLOGICALSterile liquid for injection
PlaceboBIOLOGICALSterile liquid for injection
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Eligibility Criteria
Age Range12 Months — 49 Years
SexALL
Healthy VolunteersYes
Study Sites19

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 ...

Countries:United States
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