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Investigational hMPV/RSV vaccine

Phase 1

Human Metapneumovirus Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Dec 11, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment1,530

FDA Designations

No designations recorded

Clinical trial landscape

Investigational hMPV/RSV vaccine · 1 trial · 2 indications

Phase 1 1

Indication

NCT06686654Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and OlderHuman Metapneumovirus Immunization

ACTIVE NOT_RECRUITING1,530 Analytics

PHASE1ACTIVE NOT_RECRUITING

Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older

Human Metapneumovirus Immunization

NCT066866541,530

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Study Endpoints

Primary Endpoints

Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Within 30 minutes after primary and booster vaccinations

Number of participants reporting immediate unsolicited systemic AEs

Presence of solicited injection site and systemic reactions (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Up to 7 days after primary and booster vaccinations

Number of participants reporting solicited injection site and systemic reactions

Presence of unsolicited AEs (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Up to 28 days after primary and booster vaccinations

Number of participants reporting unsolicited AEs

Presence of medically attended AEs (MAAEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Up to 6 months after primary and booster vaccinations

Number of participants reporting MAAEs

Presence of serious AEs (SAEs) and AEs of special interest (AESIs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Up to 6 months after primary and booster vaccinations

Number of participants reporting SAEs and AESIs

Presence of related SAEs, related AESIs, and fatal SAEs (regardless of causality) (Stage 1 and Stage 2 Expansion and Booster Cohorts)

Throughout the duration of the study (up to approximately 24 months)

Number of participants reporting related SAEs, related AESIs, and fatal SAEs

Presence of out-of-range biological test results (Stage 1)

Up to 7 days after primary vaccination

Number of participants with out-of-range biological tests

Presence of out-of-range biological test results (Stage 2 Booster Cohort)

Up to 7 days after booster vaccination

Number of participants with out-of-range biological tests

hMPV A serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts

At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

hMPV B serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts

At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

RSV A serum nAb titers in Stage 1 Sentinel and Main Cohorts

At pre vaccination (D01) and 28 days post-primary vaccination (D29)

nAb titers expressed as geometric mean titers (GMTs)

RSV B serum nAb titers in Stage 1 Sentinel and Main Cohorts

At pre vaccination (D01) and 28 days post-primary vaccination (D29)

nAb titers expressed as geometric mean titers (GMTs)

hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort

At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort

At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort

At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort

At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)

nAb titers expressed as geometric mean titers (GMTs)

Secondary Endpoints

hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)

At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination

RSV serum anti-F IgG Ab titers (Stage 1)

At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination

hMPV A serum nAb titers (Stage 2 Expansion Cohort)

At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposePREVENTION

Treatment Arms

Arm	Type	Description
Group A Stage 1 Sentinel Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation A
Group B Stage 1 Sentinel Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation B
Group C Stage 1 Sentinel Cohort	PLACEBO_COMPARATOR	1 IM injection of placebo
Group 1 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation C
Group 2 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation D
Group 3 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation E
Group 4 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation F
Group 5 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation G
Group 6 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation A
Group 7 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation B
Group 8 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation H
Group 9 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation I
Group 10 Stage 1 Main Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV/RSV vaccine formulation J
Group 11 Stage 1 Main Cohort	PLACEBO_COMPARATOR	1 IM injection of placebo
Group X Stage 2 Expansion Cohort	EXPERIMENTAL	1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort
Group 12 Stage 2 Expansion Cohort	EXPERIMENTAL	1 IM injection of investigational RSV monovalent vaccine
Group 13 Stage 2 Expansion Cohort	EXPERIMENTAL	1 IM injection of investigational hMPV monovalent vaccine
Group 14 Stage 2 Expansion Cohort	EXPERIMENTAL	1 IM injection of licensed RSV vaccine
Group 15 Stage 2 Booster Cohort	EXPERIMENTAL	1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort

Interventions

Name	Type	Description
Investigational hMPV/RSV vaccine	BIOLOGICAL	Investigational hMPV/RSV vaccine administered intramuscularly
Investigational hMPV vaccine (monovalent)	BIOLOGICAL	Investigational hMPV vaccine (monovalent) administered intramuscularly
Investigational RSV vaccine (monovalent)	BIOLOGICAL	Investigational RSV vaccine (monovalent) administered intramuscularly
Licensed RSV Vaccine	BIOLOGICAL	Licensed RSV vaccine administered intramuscularly
Placebo	BIOLOGICAL	Placebo administered intramuscularly
Investigational RSV+hMPV vaccine	BIOLOGICAL	Investigational RSV+hMPV vaccine administered intramuscularly

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Eligibility Criteria

Age Range60 Years to N/A

SexALL

Healthy VolunteersYes

Study Sites24

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or...

Countries:United States

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Frequently asked questions about Investigational hMPV/RSV vaccine

What is the investigational hMPV/RSV vaccine used for?

The investigational hMPV/RSV vaccine is being developed for immunization against human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) in adults aged 60 years and older. It is an mRNA vaccine candidate encapsulated in a lipid nanoparticle-based formulation, currently in Phase 1 clinical development.

Who is developing the investigational hMPV/RSV vaccine?

Sanofi (ticker: SNY) is developing the investigational hMPV/RSV vaccine. The company is conducting a Phase 1 clinical trial of this mRNA vaccine candidate for immunization against human metapneumovirus and respiratory syncytial virus in older adults.

What phase is the investigational hMPV/RSV vaccine in?

The investigational hMPV/RSV vaccine is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.

What clinical trials is the investigational hMPV/RSV vaccine in?

The investigational hMPV/RSV vaccine is being studied in one Phase 1 trial, NCT06686654. This randomized, double-blind, placebo-controlled study is evaluating the vaccine candidate in 1,530 healthy adults aged 60 years and older in the United States.

Is the investigational hMPV/RSV vaccine a monoclonal antibody?

No, the investigational hMPV/RSV vaccine is not a monoclonal antibody. It is an mRNA vaccine candidate encapsulated in a lipid nanoparticle-based formulation, designed to induce an immune response against human metapneumovirus and respiratory syncytial virus.