Active — Not RecruitingPhase 1/2

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

United States1,530 participantsStarted 2024-11-11

Plain-language summary

The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older. The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate). Overall, the study is designed to address the following goals: * Assess the safety profile of the candidate formulations. * Describe the immunogenicity profile of the candidate formulations. * Select the vaccine formulations (dose) for future development. * Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine. The study duration is as follows: -Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort Treatment duration: * Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination * Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination * Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination * Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 surgically sterile Exclusion Criteria: * Any screening laboratory parameter with laboratory abnormality \> Grade 1 deemed clinically significant by the investigator * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, persons living with stable human immunodeficiency virus (HIV) are not excluded * Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine * History of RSV and/or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months * Previous history of myocarditis, pericarditis, and/or myopericarditis * Screening electrocardiogram that is consistent with possible myocarditis, pericarditis, and/or m…

What they're measuring

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

Timeframe: Within 30 minutes after primary and booster vaccinations

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

Timeframe: Up to 7 days after primary and booster vaccinations

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

Timeframe: Up to 28 days after primary and booster vaccinations

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

Timeframe: Up to 6 months after primary and booster vaccinations

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

Timeframe: Up to 6 months after primary and booster vaccinations

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

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

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

Trial details

NCT IDNCT06686654

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-18

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