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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Metapneumovirus Infection; Respiratory Syncytial Virus Infection

Treatments: Biological: RSV/hMPV mRNA LNP 2; Biological: RSV/hMPV mRNA LNP 1; Biological: hMPV mRNA LNP 1; Biological: RSV mRNA LNP 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06237296

U1111-1295-2931 (Registry Identifier)

VAV00027 (Other Identifier)

Details and patient eligibility

About

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

Full description

Study duration per participant is approximately 6 months.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Informed consent form (ICF) has been signed and dated

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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558 participants in 7 patient groups

RSV/hMPV mRNA / LNP 1 Group 1

Experimental group

Description:

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

Treatment:

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 2

Experimental group

Description:

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.

Treatment:

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 3

Experimental group

Description:

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.

Treatment:

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 2 Group 4

Experimental group

Description:

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.

Treatment:

Biological: RSV/hMPV mRNA LNP 2

RSV mRNA / LNP 1 Group 5

Experimental group

Description:

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

Treatment:

Biological: RSV mRNA LNP 1

hMPV mRNA / LNP 1 Group 6

Experimental group

Description:

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

Treatment:

Biological: hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 7

Experimental group

Description:

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.

Treatment:

Biological: RSV/hMPV mRNA LNP 1