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Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

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Sanofi

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Healthy Volunteers
Human Metapneumovirus
Respiratory Syncytial Virus Infection

Treatments

Biological: RSV/hMPV vaccine candidate Dose B
Biological: RSV/hMPV vaccine candidate Dose A
Biological: RSV/hMPV vaccine candidate Dose L
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06134648
U1111-1287-8547 (Registry Identifier)
VBD00003

Details and patient eligibility

About

The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.

Full description

Study duration per participant:

12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.

Treatment Duration:

Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.

Enrollment

646 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.
  • Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

Exclusion criteria

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

  • Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. 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 mRNA coronavirus disease 2019 (COVID-19) vaccine
  • History of RSV and/or hMPV-associated illness, diagnosed clinically, 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 myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
  • Receipt of anticoagulants in the 3 weeks preceding inclusion
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
  • History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
  • Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
  • Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
  • Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

646 participants in 9 patient groups, including a placebo group

Sentinel Cohort: RSV/hMPV Group 0 (Dose L)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Treatment:
Biological: RSV/hMPV vaccine candidate Dose L
Sentinel Cohort: RSV/hMPV Group 1 (Dose A)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Treatment:
Biological: RSV/hMPV vaccine candidate Dose A
Sentinel Cohort: RSV/hMPV Group 2 (Dose B)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Treatment:
Biological: RSV/hMPV vaccine candidate Dose B
Sentinel Cohort: Placebo-Group 3
Placebo Comparator group
Description:
Participants will be randomized to receive a single IM injection of placebo
Treatment:
Biological: Placebo
Main Cohort: RSV/hMPV Group 1 (Dose A)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Treatment:
Biological: RSV/hMPV vaccine candidate Dose A
Main Cohort: RSV/hMPV Group 2 (Dose B)
Experimental group
Description:
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Treatment:
Biological: RSV/hMPV vaccine candidate Dose B
Main Cohort: Placebo-Group 3
Placebo Comparator group
Description:
Participants will be randomized to receive a single IM injection of placebo
Treatment:
Biological: Placebo
Booster Cohort-RSV/hMPV
Experimental group
Description:
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
Treatment:
Biological: RSV/hMPV vaccine candidate Dose A
Biological: RSV/hMPV vaccine candidate Dose B
Booster Cohort-Placebo
Placebo Comparator group
Description:
Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort
Treatment:
Biological: Placebo

Trial contacts and locations

13

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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