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A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults

ConditionsRespiratory Syncytial Virus (RSV)Human Metapneuomovirus (hMPV)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorModernaTX, Inc.

About this trial

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.

Body mass index within the range 18.5 to 35 kg/m2 (inclusive).

Disqualifiers

History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.

Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade 1.

History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.

History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • mRNA-1365 (Profile 2)

    Biological/Vaccine

    Sterile liquid for injection

  • mRNA-1345 (Profile 1)

    Biological/Vaccine

    Sterile liquid for injection

  • mRNA-1345 (Profile 3)

    Biological/Vaccine

    Sterile liquid for injection

Treatment groups

375 Participants
are divided into 5 treatment groups
Group A: mRNA-1365 (Profile 2) Dose Level 1Experimental treatment 1 intervention
Group B: mRNA-1365 (Profile 2) Dose Level 2Experimental treatment 1 intervention
Group C: mRNA-1365 (Profile 2) Dose Level 3Experimental treatment 1 intervention
Group D: mRNA-1345 (Profile 1)Active comparator 1 intervention
Group E: mRNA-1345 (Profile 3)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Time frame
Up to Day 7 (the day of study intervention and 6 subsequent days)
2

Number of Participants with Unsolicited Adverse Events (AEs)

Time frame
Up to Day 28 (the day of study intervention and 27 subsequent days)
3

Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)

Time frame
Up to End of Study (EOS) (Day 181)

Secondary outcomes

1

Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)

Time frame
Day 29
2

Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)

Time frame
Day 29
3

Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level

Time frame
Day 29

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov
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