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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

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

mRNA-1653 · 2 trials · 1 indication

Phase 1 2
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 ExposureHuman Metapneumovirus and Human Parainfluenza Infection
COMPLETED51 Analytics
NCT03392389Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy AdultsHuman Metapneumovirus and Human Parainfluenza Infection
COMPLETED124 Analytics
PHASE1COMPLETED
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
Human Metapneumovirus and Human Parainfluenza Infection
NCT0414434851
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PHASE1COMPLETED
Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults
Human Metapneumovirus and Human Parainfluenza Infection
NCT03392389124
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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 to 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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Frequently asked questions about mRNA-1653

What is mRNA-1653 used for?

mRNA-1653 is an investigational vaccine being developed for the prevention of Human Metapneumovirus and Human Parainfluenza Infection. It is designed to target both human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3). The vaccine is currently in Phase 1 clinical development and is not yet approved.

Who makes mRNA-1653?

mRNA-1653 is being developed by Moderna, Inc. (NASDAQ: MRNA). The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine in healthy adults and children.

What phase is mRNA-1653 in?

mRNA-1653 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 175 participants. The vaccine is investigational and has not been approved by regulatory authorities.

What clinical trials is mRNA-1653 in?

mRNA-1653 has been studied in two completed Phase 1 trials: NCT03392389, which evaluated safety, reactogenicity, and immunogenicity in healthy adults (124 participants), and NCT04144348, which assessed safety and immunogenicity in healthy adults and children aged 12 to 59 months with prior exposure (51 participants). Both trials were conducted in the United States.

How does mRNA-1653 work?

mRNA-1653 is an mRNA-based vaccine that encodes antigens from human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3). It is designed to induce an immune response against these respiratory viruses, potentially providing protection against infection.