Test TrialX Trial - Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

RSV and hMPV Vaccine Study in Older Adults

Recruiting
60 years or above
All
Phase 1/2
210 participants needed
3 Locations

Study Overview

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.

Study Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus Infection, Healthy Volunteers, Human Metapneumovirus
  • Age: 60 years or above
  • Gender: All

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.

Updated on 03 Dec 2024. Study ID: NCT06134648

This study investigates the safety and immune response of a vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in adults aged 60 years and older. The purpose is to evaluate how the body reacts to the vaccine and to ensure it is safe for use. The study will also look at the effects of a booster shot given 12 months after the first vaccination in some participants.

Participants in the study will receive a single intramuscular injection of the vaccine. Some participants will receive a booster injection after 12 months. The study will involve regular follow-ups to monitor the participants' health and the body's response to the vaccine.

  • Who can participate: Adults aged 60 years or older can participate. Participants must not be pregnant or breastfeeding and should have stable health conditions.
  • Study details: Participants will receive one injection of the investigational vaccine. Some will also receive a booster shot after 12 months. The study will involve regular health check-ups to monitor safety and immune response.
  • Study timelines: The study will last 12 months for most participants and 24 months for those receiving a booster.

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