Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-02-11

Brief Summary

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The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.

Treatment:

* RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
* RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
* RSV mRNA / LNP 1 at 1 dose or,
* hMPV mRNA / LNP 1 at 1 dose

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Detailed Description

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Study duration per participant is approximately 6 months.

Conditions

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Respiratory Syncytial Virus Infection Healthy Volunteers Metapneumovirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

* Participants, Investigators and site staff remain blinded during study conduct, except dedicated study staff preparing/administering the study intervention.
* Sponsor study staff will remain unblinded, except laboratory staff who handle primary/secondary endpoints

Study Groups

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RSV/hMPV mRNA / LNP 1 Group 1

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.

Group Type EXPERIMENTAL